FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Vanguard microplasty slidex femoral 4-in-1 block, 60 mm, stainless steel; Ref. 32-485102.
- Recall number
- Z-1446-05
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Vanguard microplasty slidex femoral 4-in-1 block, 60 mm, stainless steel; Ref. 32-485102.
- Status
- Terminated
- Initiated
- 2005-05-16
- Posted
- 2005-08-31
- Terminated
- 2005-09-08
- Reason
- The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
- Root cause
- Other
- Action
- Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.
- Quantity
- 462
- Distribution
- Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
- Lot, serial or model codes
- Lots 800030, 107960, 150150, 244090, 341470, 340460, 110160, 089070, 150560, 246460, 246470, 281680, 128100, 281670, 281690, 289650, 299480, 302850, 480060, 480070, 480080, 333930, 490710, 490720, 521300, 571400, 208950, 059810, 208940, 471980, 667580, 649910, 822020, 851780, 939010, 952030, 710250, 783350, 858300 and 104360.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTZ
- 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