Z-0011-06

Allocraft TLIF Bone Inserter

Name: Z-0011-06 Allocraft TLIF Bone Inserter
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-04-04
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-04-04 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Allocraft TLIF Bone Inserter on 2005-04-04. The reason FDA records is "Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0011-06
Status: Terminated
Initiated: 2005-04-04
Posted: 2005-10-07
Terminated: 2007-08-15
Recalling firm: Howmedica Osteonics Corp
Product: Allocraft TLIF Bone Inserter.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA 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 in commerce: 9
Distribution: The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.
Product codes and lots: Catalog No. 483600100; Lot Code: 04C570

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)