Recalls / —

—#137732

Product

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

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K111663

Affected lot / code info

Part number:856135060 Lot: 061300

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Domestic: None. International: Netherlands and Japan

Timeline

Recall initiated

2015-06-04

Posted by FDA

2015-07-10

Terminated

2016-03-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #137732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.