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.
FDA Recall Z-2877-2018 · Posted None
Advertisement
Recalling FirmTriMed Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2018-04-16
Date Terminated2021-01-28
Product Quantity722
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
Firm 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 [email protected] 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: [email protected].
TriMed will replace the potentially defective plates with plates that have been manufactured and confirmed to meet TriMeds specifications.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution in the state of TX and countries of Australia, China Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement