FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
- Recall number
- Z-2505-2010
- Recalling firm
- Biomet, Inc.
- Product
- Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
- Status
- Terminated
- Initiated
- 2010-07-28
- Posted
- 2010-09-25
- Terminated
- 2012-10-01
- Reason
- 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
- Employee error
- 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.
- Quantity
- 331 total for both products
- Distribution
- US, Australia, Canada, Mexico, Chile, Japan.
- Lot, serial or model codes
- 106623, 106624, 106625, 106626, 106627, 106628 110405 and 110423.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28