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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Hip and Knee Replacement System

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 Class 2 Device Recall Modular Hip and Knee Replacement Systemsee related information
Date Initiated by FirmNovember 15, 2007
Date PostedFebruary 26, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall NumberZ-0925-2008
Recall Event ID 45947
510(K)NumberK952970 
Product Classification Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
ProductStryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430
Code Information Catalog Number: 6485-3-713; Lot Codes: LCDCE,LCDE1, TEC027, TEC055, TEC055B, TEC055C, TEC087, TEC087A, TEC087A1, TEC087B, TEC087B1, TEC087C, TEC087D, TEC097E, TEC257, TEC283A.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRita Intorella
201-831-6633
Manufacturer Reason
for Recall		Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
FDA Determined
Cause 2		Process design
ActionOn November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.
Quantity in Commerce803 total, all sizes
DistributionNationwide Distribution
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 = JDI
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