—#105423

Product

OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K002757
Affected lot / code info: Item: 150368; Lot 081650

Why it was recalled

Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.

Recalling firm

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

Distribution

Distribution pattern: Distributed only in The Netherlands.

Timeline

Recall initiated: 2011-11-01
Posted by FDA: 2012-01-11
Terminated: 2012-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105423. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.