FDA recall Z-2877-2018

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 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

Worldwide Distribution in the state of TX and countries of Australia, China Sweden

Key facts

Status

Terminated

Initiation date

2018-04-16

Report date

2018-08-29

Termination date

2021-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2877-2018