—#38862

Product

Allocraft TLIF Bone Inserter.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog No. 483600100; Lot Code: 04C570

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.

Timeline

Recall initiated: 2005-04-04
Posted by FDA: 2005-10-07
Terminated: 2007-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.