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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis II Nonporous FinStem Tibial Punch

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 Class 2 Device Recall Genesis II Nonporous FinStem Tibial Punchsee related information
Date Initiated by FirmAugust 29, 2006
Date PostedOctober 03, 2006
Recall Status1 Terminated 3 on April 12, 2010
Recall NumberZ-0010-2007
Recall Event ID 36293
Product Classification Tibial Punch - Product Code LXH
ProductGenesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Code Information 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.
FEI Number 1020279
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactVictor Rocha
901-399-6771
Manufacturer Reason
for Recall		Tibial punches were not manufactured to specification and could break at the tip during use.
FDA Determined
Cause 2		Other
ActionRecall 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.
Quantity in Commerce4800 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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