Recalls / —

—#92213

Product

Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

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

M402080.

Why it was recalled

A knee implant labeled as left was opened and the package actually contained a right knee implant.

Root cause (FDA determination)

Process control

Action the firm took

On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan

Timeline

Recall initiated

2010-04-20

Posted by FDA

2010-08-10

Terminated

2011-01-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #92213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.