—#100968

Product

Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023546
Affected lot / code info: Part # 183132. Lot # 947480.

Why it was recalled

The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.

Root cause (FDA determination)

Employee error

Action the firm took

Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.

Timeline

Recall initiated: 2011-07-06
Posted by FDA: 2011-08-04
Terminated: 2012-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100968. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.