Recall Z-0366-2020— TriMed Inc.

Name: FDA recall Z-0366-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-15

Class II · Terminated

Class II FDA medical device recall by TriMed Inc., initiated 2018-08-15. It names one FDA 510(k) clearance: K060041. 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: 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..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060041 — TRIMED BONE PLATESTriMed, Inc.·cleared 2006-02-07

K-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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.