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.
This recall has been terminated (originally issued April 16, 2018).
- Company
- Trimed Inc.
- Recall Initiated
- April 16, 2018
- Terminated
- January 28, 2021
- Recall Number
- Z-2877-2018
- Quantity
- 722
- Firm Location
- Santa Clarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution in the state of TX and countries of Australia, China Sweden
Lot / Code Info
Lot Numbers: 10003, 10017
Root Cause
Process control
Action Taken
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: Telephone*: 800-633-7221, Email: quality@trimedortho.com. TriMed will replace the potentially defective plates with plates that have been manufactured and confirmed to meet TriMeds specifications.