—#138179

Product

A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

FDA product code: HYA — Forceps, Wire Holding
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524

Why it was recalled

Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

Root cause (FDA determination)

Vendor change control

Action the firm took

On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning 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: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica

Timeline

Recall initiated: 2015-06-17
Posted by FDA: 2015-07-14
Terminated: 2016-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.