Recall Z-2877-2018 ยท HRS Plate, Fixation, Bone
TriMed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
| Date | Apr 16, 2018 |
| Status | Terminated |
| Reason | Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate |
| Root cause | Process control |
| Action | Tri-Med issued notification on April 16, 2018 requesting: Determine the lot number of all Ulnar Osteotomy Compression Plates, Short (UOCP-S) .If you have UOCP-S plates with the lot numbers listed (10003, 10017): o Remove the UOCP-S plates from the tray and quarantine it. Do not use this plate. Contact TriMed at quality@trimedortho.com or call 800-633-7221. TriMed will arrange have the plate(s) returned to the company and replaced. Return the Recall Response card attached to this letter to TriMed as soon as possible. Contact TriMed via telephone or email as per below if you have any questions |
| Quantity | 722 |
| Distribution | Worldwide Distribution in the state of TX and countries of Australia, China Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043263 | TRIMED OSTEOTOMY PLATE TriMed, Inc., Jan 14, 2005 |