—#74060

Product

Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.

FDA product code: JDQ — Cerclage, Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K982545
Affected lot / code info: Lot 568400.

Why it was recalled

The outer package is properly labeled, but the inner package may be labeled as a femoral component.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.

Timeline

Recall initiated: 2008-09-24
Posted by FDA: 2008-11-09
Terminated: 2009-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.