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U.S. Department of Health and Human Services

Class 2 Device Recall Trident Hemispherical Acetabular Shell

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 Class 2 Device Recall Trident Hemispherical Acetabular Shellsee related information
Date Initiated by FirmMay 29, 2007
Date PostedAugust 13, 2009
Recall Status1 Terminated 3 on August 17, 2009
Recall NumberZ-1685-2009
Recall Event ID 50097
510(K)NumberK013676 
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
ProductTrident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.
Code Information Product Number: 508-11-72J; Lot Number: 20282301.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactRita Intorella
201-831-5825
Manufacturer Reason
for Recall		Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301
FDA Determined
Cause 2		Labeling mix-ups
ActionStryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.
Quantity in Commerce2 units
DistributionDistributed to 2 Stryker branches.
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.
510(K) Database510(K)s with Product Code = MEH
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