—#94040

Product

Modular Microplasty Cup inserter 3/8" thread , REF 31-400600

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 658180, 658190 and 907630.

Why it was recalled

There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" The recalling frim conducted tests to determine the effects of theis change in materials. The testing showed that the wire would oxidize and there would be early failure of the device.

Root cause (FDA determination)

Employee error

Action the firm took

The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.

Recalling firm

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

Distribution

Distribution pattern: US, Australia, Canada, Mexico, Chile, Japan.

Timeline

Recall initiated: 2010-07-28
Posted by FDA: 2010-09-25
Terminated: 2012-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94040. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.