Recall Z-2058-2015— Biomet, Inc.

Name: FDA recall Z-2058-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-06-04, terminated 2016-03-22. It names one FDA 510(k) clearance: K111663. Product: A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw. Reason: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2016-03-22
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K111663 — TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.·cleared 2012-03-12

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

A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw

Reason for recall

Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

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