Recall Z-1234-2023 ยท LZD Joint, Temporomandibular, Implant
Stryker Leibinger GmbH & Co. KG
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
| Date | Mar 8, 2023 (initiated Dec 6, 2022) |
| Status | Open, Classified |
| Reason | Device was shipped without having regulatory approval. |
| Root cause | No Marketing Application |
| Action | Stryker sent an Urgent Medical Device Recall letter dated December 21, 2022, to affected customers. The letter identified the affected product, problem and actions to be taken. This event is isolated to a single patient-specific product that at the time of recall notification, has already been retrieved by the recalling firm. F questions or concerns, contact Customer Service +1 800 962-6558. Please confirm the acknowledgement of this notification to CMF-custserv@stryker.com. |
| Quantity | 1 unit |
| Distribution | Distribution of one unit only to a single customer in MA (USA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.