—#39198

Product

Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530.

FDA product code: HTZ — Instrument, Cutting, Orthopedic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lots 692030, 847270, 893240, 991260, 103470, 103440, 136560, 271330, 170710, 356500, 399630, 399640, 564090, 712190, 744790, 757850, 770410, 994540 and 863650.

Why it was recalled

The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.

Root cause (FDA determination)

Other

Action the firm took

Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.

Timeline

Recall initiated: 2005-05-16
Posted by FDA: 2005-08-31
Terminated: 2005-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.