Recalls / —

—#84221

Product

Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

FDA product code

HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot 027410.

Why it was recalled

These surgical instruments are etched with incorrect measurement markings.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

Nationwide Distribution -- Including the state of Texas.

Timeline

Recall initiated

2009-08-06

Posted by FDA

2009-09-08

Terminated

2010-10-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #84221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.