FDA recall Z-0366-2020

TriMed Inc. · Class II · device

Product

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

Reason for recall

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

Distribution

US Nationwide distribution in the states of MD, UT.

Key facts

Status
Terminated
Initiation date
2018-08-15
Report date
2019-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2020