Allocraft TLIF Bone Inserter.
FDA device recall Z-0011-06 · posted 2005-10-07 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 9
- Distribution
- The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.
- Date initiated
- 2005-04-04
- Date posted
- 2005-10-07
- Date terminated
- 2007-08-15
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.