—#124345

Product

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

Why it was recalled

Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Beginning November 25 Urgent recall electronic notices were sent by Biomet UK to all distributors with hospitals outside the USA notified by ground mail November 27,2013. The notification identified the product and reason for the recall, asking for immediate location and discontinued use of the product and return to Biomet UK, Ltd. Questions can be addressed to Biomet USA at 01 574-372-1570 M-F 8 am to 5 pm.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.

Timeline

Recall initiated: 0013-11-26
Posted by FDA: 2013-12-13
Terminated: 2014-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.