Recall Z-0786-2022 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
| Date | Feb 15, 2022 |
| Status | Terminated |
| Reason | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. |
| Root cause | Process control |
| Action | The firm notified the foreign competent authority via email on 2/15/2021 which included a copy of the recall letter. Once the foreign competent authority approves the recall, the recall letter will be sent to the foreign consignee. The recall letter is dated 2/15/2022 and describes the product, the issue, potential risks, and the actions needed. The actions included (1) informing individuals within their organization who need to be aware of this device recall; (2) immediately check all stock areas and/or operating room storage to determine if there is any affected product; (3) quarantine an |
| Quantity | 1 package |
| Distribution | International distribution to the country of France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090692 | ORTHOLOC 2.0/2.4 PLATE SYSTEM Wrightmedicaltechnologyinc, May 8, 2009 |