Recall Z-1567-2022 ยท MPK Semi-Constrained Metal/Polymer Finger Joint Prosthesis
Wright Medical Technology, Inc.
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
| Date | Jul 27, 2022 |
| Status | Open, Classified |
| Reason | An incorrect sizing label was applied to the carton packaging. |
| Root cause | Error in labeling |
| Action | 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 |
| Quantity | 17 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.