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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 Shell see related information
Date Initiated by Firm May 29, 2007
Date Posted August 13, 2009
Recall Status1 Terminated 3 on August 17, 2009
Recall Number Z-1685-2009
Recall Event ID 50097
510(K)Number K013676  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product Trident 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Rita Intorella
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
Action Stryker 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 Commerce 2 units
Distribution Distributed to 2 Stryker branches.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.