FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
- Recall number
- Z-1186-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
- Status
- Terminated
- Initiated
- 2008-01-16
- Posted
- 2008-08-20
- Terminated
- 2009-09-22
- Reason
- The weld at the lock location may fracture during impaction.
- Root cause
- Device Design
- Action
- Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.
- Quantity
- 59
- Distribution
- Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
- Lot, serial or model codes
- Lot 095207.
- 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