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Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

I’m not going to beat around the bush. I don’t like conducting recalls. Who would? Paradoxically, recalling product from the field is counter-productive, yet so necessary when human health is involved. The negative factor of a recall is incalculable and only realized after you finish your first recall; it really is an exercise in futility. You vow that “this will never happen again on my watch.” Never again, you say. Then it happens again (and again) for some companies. I receive FDA recall updates via email. It’s eye-opening. I’m involved with this type of activity because, frankly, companies need assistance (and guidance) to climb that costly and steep (K2-steep) recall mountain. Additionally, and as you have probably heard, recalls aren’t cheap.

After you have committed to FDA and then summarily worked an inordinate amount of time to resolve the clear and present issues, you still feel empty inside. Collaterally, it can affect the morale of an entire company. Yes, I know, the act of removing defective (basically adulterated) product from the field to prevent further human use is an overt responsibility FDA has put in place to protect people’s lives. I support that principle. The process of conducting a recall is, never the less, arduous. Timeliness is an important factor to reckon with as well, which immediately puts even healthy companies on the defensive. It involves learning curves, blame and forced interaction with governmental agencies. That being said, recalls are a necessary fact of life and are meant to be dealt with in a methodical manner.

A Brief History Lesson

From 1983 to 1989, FDA conducted a six-year study to determine the causes of voluntary recalls. That study found that 44% of all voluntary recalls could have been prevented if adequate design controls were used. Fundamentally, poor design was a leading cause of voluntary recalls. Another study was performed on recall data from 2003 to 2012, and design was cited as one of the most frequent causes of recalls. Design has an important and direct real world bearing on device quality, safety and effectiveness. Many postmarket problems with medical devices can be traced back to poor design.

Additionally, 510(k)-cleared devices are 10 times more likely (or more) to be recalled than premarket approved devices. It is of concern that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.

Steps That You Can Take to Minimize the Steep Climb

A recall can be disruptive to a company’s operation and business, but your company can take a few steps to minimize the troublesome effects of not being prepared. First, you should establish and enable an up-to-date written contingency plan for use in initiating and affecting a recall in compliance with the regulations. An ounce of prevention will afford your company a pound of efficiency and effectiveness. Second, the use of sufficient and accurate coding of your device products (packaging and labeling included, of course) to make possible positive lot identification and to facilitate effective recall of all violated lots is an organizational approach you usually upgrade after your first recall. I know that your company will never have a recall, but you should prepare for the possibility. Third, maintain cogent and complete product distribution records to facilitate location of device products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product.



Three Recall Classifications

FDA will assign your company a Classification after some time.

Class I recalls are for dangerous or defective products that could cause serious health problems or even death.

Class II recalls address products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Class III recalls involve products that are unlikely to cause adverse health reaction, but that violate FDA labeling or manufacturing regulations.



What FDA Says about Recalls

FDA indicates that a “recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors must carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.” FDA goes on to say that a “recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.”

Here is How the Process Works

What adds to the complexity of a recall is that the initiation, classification and termination process of a medical device recall requires documented interaction and collaboration amongst your company recall team, the Office of Regulatory Affairs District Office (ORA) and the Center for Devices and Radiological Health (CDRH). If you’re not used to dealing with FDA, this could be an enlightening experience in that you are forced to deal with a subject that is not part of your everyday work, and you are under the microscope from day one.

The recall process typically begins with the device manufacturer becoming aware of the issue warranting a recall action, initiating the recall and notifying FDA’s ORA district office. The ORA district office issues a 24-hour alert to CDRH and a recall classification recommendation. CDRH conducts a final review and classification. As I said, some of the collateral damage occurs when the recall is publicly posted online within a day of classification. Yes, your recall is known to your competitors. Believe me, it causes much trepidation among a company’s regulatory affairs and sales and marketing teams.

Your company’s recall strategy (for a firm-initiated recall to fit individual circumstances) should include at least:

  • Results of a health hazard evaluation. When (and if) FDA does a post-recall inspection, they want to make sure that this documentation is in place to show how the decision was made to move forward with a recall and to what extent returned product was coming back to the manufacturer
  • A “buttoned-up” process for identifying product to the greatest degree necessary (e.g. to locate it in the field)
  • The degree to which the product’s deficiency is obvious to the consumer or the user. Adulterated can mean anything from mislabeling to contaminated product to not following the cGMP-QS Regulations.
  • How much of the product remains unused and how much has been used already in the market place
  • Is there still product availability (for the patient’s dependency)?

FDA will review this strategy and make comment (one way or the other). Don’t delay the initiation of the recall waiting for an FDA decision unless FDA vehemently opposes the initiation. This is where this situation becomes a very gray area, indeed. If you wait, “you’re not engaged and proactive.” If you go forward in a timely fashion, you could get a comment like “this strategy doesn’t do justice to the recall—start again.” Your recall team, distributors and customers/users can become impatient and undeniably frustrated.

The conduct of the actual recall is driven by a few important factors, with the most important considerations being the degree of hazard and the extent of distribution. Taking into consideration the consumer use level, the wholesale level and the retail level of use a decision on extent becomes self-explanatory unless you don’t generate metrics of that nature. Time intervals can be affected by recall complexity, information availability from firms, amount of industry guidance required, workloads and staff resources. The more questions that your company cannot properly answer during the recall, the higher the propensity that there will be an FDA inspection in the future.

The information that will be important to generate, acquire and potentially give FDA includes at least the following:

  • The identity of the product(s) involved
  • Reason for the recall. Putting this into your corrective action system is a good way to organize this information for future reference. You’ll be dealing with reams of information. Having a recall coordinator to organize and implement records of the recall is imperative.
  • Evaluation of the risks involved could necessitate the possibilities of enabling re-design, reworking, initiating a well-documented destruction strategy, etc.
  • Of course, the quantitative aspects of this recall are high on a platform of reconciliation and accountability. Distribution records should be impeccable to at least the first consignee. Putting the distributors on your approved supplier list by conducting an audit of their ability to recall (reconciliation and accountability) is a must these days. What if you have records to the first consignee (the distributor), and the first consignee doesn’t have ensuing records out in the field! Your company is accountable, first and foremost.
  • Distributor information, for logistical purposes
  • As indicated, the recall strategy and detailed plans
  • Identification of the recall team leader
  • Dealing with the fact that FDA will place this recall in the weekly FDA Enforcement Report until resolved
  • Related complaints and any adverse events that have been addressed in the Corrective Action Process.

Setting up a Budget

Some recalls become worldwide problems and tend to not present companies in a positive light. Your company is doing everything it must do to turn this colossal negative into a proactive occurrence. Much money is spent on damage control and physically bringing the product back as soon as possible. Some companies set up budgets to deal with this unplanned spending spree. If you’re not set up to deal with the outlay of funds or your company isn’t financially stable, this could be just enough to cease operations and have to regroup as an organization. The recall strategy will specify whether a public warning is necessary, and if so, either a general public warning using the news media or a public warning through trade press will be issued. Your budget should include “mending fences” and smoothing out misconceptions and misinterpretation by customers and distributors. I have seen issues like this go to court and, of course, now you’re talking about more monetary expenditure and more bad press. The collateral damage can be expressed in compromising long-standing relationships with distributors and customers/end-users alike which, as you can well imagine, takes on a very negative outcome.

Effectiveness Checks

The purpose of effective checks is to verify that all consignees within the recall scope specified by the released strategy have received notification about the recall and have taken the proper action. The methods for contacting consignees may be undertaken by documented 1) personal visits, 2) telephone calls, 3) letters or 4) a combination of all of the above. FDA wants periodic and detailed updates on how your plan is going. Your company will ordinarily be responsible for conducting effectiveness checks, but FDA will assist with this effort when necessary or if they feel as though your company is not doing everything it can to resolve having adulterated product in the field. Again, the recall strategy will specify the method(s) and the level of effectiveness based upon time and efficiency. If FDA suspects that your company is not doing everything it can to resolve the issues this will be, as I mentioned before, something they will take note of if and when your company is subjected to post-recall inspection.

Contents of Recall Communications

A recall communication should be written and sent via telegrams, mailgrams, first-class, return, receipt request, registered mail or email. The communication should be marked as being urgent in nature and for a Class I, II or III recall. Telephone calls must be confirmed using one of the above methods. Some sales and marketing people want to use this opportunity to talk directly with their customers, voice-to-voice. Recall communications should be brief and to the point and not contain verbose language or lawyer-speak. Your customers and distributors must understand why this situation is happening and what specific instructions they must follow to do their part. No matter the views of sales and marketing, this communication must not contain irrelevant qualifications, promotional materials or any other verbiage that will distract from the task at hand. Of course, consignees that receive a recall communication should immediately carry out the instructions in a timely and accurate manner.

So, You Want this Recall to End…

FDA will determine when the recall is terminated when they reasonably deduct that the recall strategy has been followed, the product(s) in question have been removed from the field and that the product has been summarily dispositioned by the recalling company, e.g. proof of destruction or rework. Written notification that the recall is over is always issued by the FDA District Office to the recalling firm. You can formally request that the recall be terminated if it seems to be never-ending. That doesn’t necessarily mean that your wish will come true. As I said earlier, this is not only an arduous task, but it can wreak havoc with a company’s self-esteem.

It’s a Wrap

In 2016, FDA indicated that there were 39 Class I recalls. In 2017, the rate of Class I recalls is on track to double that number by year-end. Why are there so many Class I recalls in recent years? In my opinion, this has to do with the increase in volume of devices being commercialized. Also, as I mentioned in the factoid above, clinical studies are basically relegated for higher risk devices, and companies are doing the bare minimum to get products to market. Even though clinical studies could mitigate the risks involved with medical device applications and use, these studies are time-consuming and costly. Basically, the real clinical studies are being achieved after the device is placed in the market place.

The 1980s study that was conducted by FDA to ascertain the causes of recall was instrumental in influencing the Safe Medical Devices Act of 1990 (SMDA). After this recall study, discussions occurred among the medical device industry, FDA and Congress about the inclusion of preproduction requirements (e.g. Design Controls) in the current good manufacturing practices. Industry was concerned that such requirements would stifle research, while FDA wanted to ensure that once research entered a development phase, the development would be defined and controlled. With the passage of the SMDA, FDA was given authorization by Congress to add design control requirements to medical devices. They were subsequently written into the 1996 Quality System Regulation, which became effective June 1, 1997. The preamble to the regulation provides a lot of useful information about industry's concerns at the time, FDA’s intent and the context for design control expectations. Specifically, design validation can include clinical studies as one important method to meet the user needs and help mitigate issues related to safety and efficacy in the field.

Related Resources:

Design Intent: Do I Need to Perform
Verficiation and Validation?

Don't Treat Your FDA Inspection Like an ISO Audit

When Do I See a CAPA Specialist?

Pareto Analysis: Tools for New Product Testing


John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC



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