Medical Device Recall: Z-0010-2007

FDA Recalls dataset · Firm: Smith & Nephew Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-08-29 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2007.

Recall Res Number
Z-0010-2007
Recalling Firm / Manufacturer
FEI Number
1020279
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-08-29
Date Posted
2006-10-03
Date Terminated
2010-04-12
Product Code
LXH
Event Number
36293
Product Quantity
4800 units
Product Description Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

Reason for Recall Tibial punches were not manufactured to specification and could break at the tip during use.

Action Details Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.

Distribution Pattern Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.

Code Information / Serial Numbers Catalog Number 71440480 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Numbers 71440482 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Number 71440484 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Number 71440486 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.

Related Establishments / Registrations

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