Recalls / —

—#66867

Product

Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K915132

Affected lot / code info

Lot Number: 448530.

Why it was recalled

Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

Root cause (FDA determination)

Packaging process control

Action the firm took

Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern

Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.

Timeline

Recall initiated

2007-12-12

Posted by FDA

2008-01-31

Terminated

2008-06-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #66867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.