Z-2877-2018 Class II Terminated
FDA device recall Z-2877-2018 was initiated by TriMed Inc. on April 16, 2018 and is designated Class II. 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 The recall status is terminated (terminated January 28, 2021). Affected quantity: 722.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- April 16, 2018
- Termination Date
- January 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 722
Product Description
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.
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 Pattern
Worldwide Distribution in the state of TX and countries of Australia, China Sweden
Code Information
Lot Numbers: 10003, 10017