—#82122

Product

Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K002757, K043547
Affected lot / code info: All lots. Lots 681420 and 989750.

Why it was recalled

The retaining ring may fall out of the instrument during surgery.

Root cause (FDA determination)

Process control

Action the firm took

Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.

Timeline

Recall initiated: 2009-05-19
Posted by FDA: 2009-06-29
Terminated: 2010-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82122. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.