—#86904

Product

Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.

Why it was recalled

The locking hook tabs may fracture and fragments remain in the patient post-operatively.

Root cause (FDA determination)

Device Design

Action the firm took

Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.

Timeline

Recall initiated: 2009-12-01
Posted by FDA: 2010-01-15
Terminated: 2010-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.