Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
FDA device recall Z-2505-2010 · posted 2010-09-25 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 331 total for both products
- Distribution
- US, Australia, Canada, Mexico, Chile, Japan.
- Date initiated
- 2010-07-28
- Date posted
- 2010-09-25
- Date terminated
- 2012-10-01
- Location
- Warsaw, IN
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