Recall Z-2877-2018— TriMed Inc.
Class II · Terminated
Class II FDA medical device recall by TriMed Inc., initiated 2018-04-16, terminated 2021-01-28. It names one FDA 510(k) clearance: K043263. 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.. 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.
- Recalling firm
- TriMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-16
- Terminated
- 2021-01-28
- Firm location
- Santa Clarita, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.