—#67214

Product

Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 095207.

Why it was recalled

The weld at the lock location may fracture during impaction.

Root cause (FDA determination)

Device Design

Action the firm took

Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.

Timeline

Recall initiated: 2008-01-16
Posted by FDA: 2008-08-20
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.