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Terminated

Allocraft TLIF Bone Inserter.

FDA Recall Z-0011-06 · Posted 2005-10-07

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-04-04
Date Terminated2007-08-15
Product Quantity9

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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