FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Allocraft TLIF Bone Inserter.
- Recall number
- Z-0011-06
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Allocraft TLIF Bone Inserter.
- Status
- Terminated
- Initiated
- 2005-04-04
- Posted
- 2005-10-07
- Terminated
- 2007-08-15
- Reason
- Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
- Root cause
- Other
- Action
- The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required.
- Quantity
- 9
- Distribution
- The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.
- Lot, serial or model codes
- Catalog No. 483600100; Lot Code: 04C570
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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