Dental Implant Recalls

February 11, 2019

When a dental implant device is recalled, the impacts for dental practices will be numerous. Understanding those impacts and how to manage implant recalls can save time and money but more importantly, demonstrate your dental practice’s commitment to patient safety.

Awareness of Recalls is Key

Awareness of dental implant recalls may occur through notification from manufacturers, through your professional networks such as Health Canada or if in the US via the FDA (Food and Drug Administration) or from your own experience. There are a number of different levels of recall and not all will require revision surgery for your patients. In the US, FDA classifies implant recalls in the following way.

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, these situations are also considered recalls.

(Source: US Food and Drug Administration sighted 14 May 2018 https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129337.htm)

Managing Recalls

Once you confirm the device’s failure or reasons why the device is recalled you need to identify your use of the device across your patient list. Leading edge Inventory management systems such as Sowingo make it incredibly easy for your practice to identify how many patients received the recalled implant device. Sowingo ensures you document the lot id of the device against the patient id of each patient who received the implant. Once you generate your list of patient ids you can develop your action plan.

The exact nature of the recall will determine the actions you need to take with each patient. Actions may vary from notifying your patients that you need to book them for revision surgery as a treatment option or you may just need to ask patients to contact you if they experience any symptoms. Those patients without immediate symptoms should be monitored for any change in status.