FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel; Ref. RD140632.
- Recall number
- Z-1452-05
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel; Ref. RD140632.
- 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
- 157
- 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 061810, 217860, 170830, 195550, 467300, 481550, 450420, 602570, 608410, 576640, 024590, 388080 and 840080.
- 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