FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

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Products

Modular Microplasty Cup inserter 3/8" thread , REF 31-400600
Brand
Biomet, Inc.
UPC
658180, 658190 and 907630.

Units Affected

331 total for both products

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