Recalls / —

—#39192

Product

Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629.

FDA product code

HTZ — Instrument, Cutting, Orthopedic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lots 147360, 201140, 310920, 238700, 238710, 397060, 467290, 481540, 523300, 607880, 024490, 560790 and 761870.

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 #39192. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.