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Terminated

Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605

FDA Recall Z-2505-2010 · Posted 2010-09-25

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-07-28
Date Terminated2012-10-01
Product Quantity331 total for both products

Reason for Recall

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.

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

US, Australia, Canada, Mexico, Chile, Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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