Wright Medical Technology, Inc. Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

An incorrect sizing label was applied to the carton packaging.

Recommended Action

Per FDA guidance

The recalling firm issued letters dated 7/27/2022 to Health Care Professionals, Operators of Medical Devices, and Distributors. Distributors received the letter via email. The medical facility received the letter via FedEx. The letter informed the consignee of the product affected, product description, product issue, potential risks, and the actions needed by customers and distributors. The actions included (1) Immediately check their internal inventory to locate the product and remove it from their point of use and isolate/quarantine it to prevent accidental usage; (2) Return the enclosed business reply form by email to confirm receipt of the notification and document product segregation. The form is to be returned by 8/10/2022; (3) Return all affected product in their possession. Hospitals are instructed to contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Branches/Hub are to return the affected devices to the address specified in the letter; (4) Ensure that personnel within the facility are aware of this communication and all required actions are completed; and (5) If product has been further distributed, notify the applicable parties at once regarding the recall.