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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker Orthopaedics Restoration Gap Plate Screw

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  Class 3 Device Recall Stryker Orthopaedics Restoration Gap Plate Screw see related information
Date Initiated by Firm June 26, 2009
Date Posted September 14, 2009
Recall Status1 Terminated 3 on July 27, 2010
Recall Number Z-2141-2009
Recall Event ID 52713
510(K)Number K873251  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 50 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Code Information Catalog number: 2080-0050; GAP PLATE SCREWS XEHMKE 06-Jul-2013 GAP PLATE SCREWS K1RMLE 22-Jul-2013 GAP PLATE SCREWS K1JMLE 23-Jul-2013 GAP PLATE SCREWS 7DYMNE 16-Sep-2013 GAP PLATE SCREWS 7E0MNE 16-Sep-2013 
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
Manufacturer Reason
for Recall
Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
Quantity in Commerce 51,113 total - all sizes.
Distribution Worldwide Distribution
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 = OSTEONICS CORP.