Device 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.
Z-2877-2018
Product summary
- Firm
- TriMed Inc.
- Event
- Event 80487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 722
- Official record key
device-enforcement:Z-2877-2018
Official wording
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
Code information: Lot Numbers: 10003, 10017
Distribution pattern: Worldwide Distribution in the state of TX and countries of Australia, China Sweden
Derived failure modes
-
Unknown
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