Recall Z-0394-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0394-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-03

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-10-03, terminated 2015-12-18. It names one FDA 510(k) clearance: K011583. Product: Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.. Reason: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-03
Terminated: 2015-12-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011583 — SPIKED WASHERSynthes (Usa)·cleared 2002-01-30

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

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Reason for recall

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

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