Medical Device Recall: Z-0011-06

FDA Recalls dataset · Firm: Stryker Howmedica Osteonics Corp. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-04-04 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-06.

Recall Res Number
Z-0011-06
Recalling Firm / Manufacturer
FEI Number
3003070421
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-04-04
Date Posted
2005-10-07
Date Terminated
2007-08-15
Product Code
LXH
Event Number
31984
Product Quantity
9
Product Description Allocraft TLIF Bone Inserter.

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 Details 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.

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

Code Information / Serial Numbers Catalog No. 483600100; Lot Code: 04C570

Related Establishments / Registrations

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