FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2877-2018
- Recalling firm
- TriMed Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-04-16
- Posted
- not on file
- Terminated
- 2021-01-28
- 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: 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.
- Quantity
- 722
- Distribution
- Worldwide Distribution in the state of TX and countries of Australia, China Sweden
- Lot, serial or model codes
- Lot Numbers: 10003, 10017
- 510(k) numbers
- ["K043263"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3001236812
- Firm city
- Santa Clarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28