| Class 2 Device Recall Modular Hip and Knee Replacement System | |
Date Initiated by Firm | November 15, 2007 |
Date Posted | February 26, 2008 |
Recall Status1 |
Terminated 3 on September 22, 2008 |
Recall Number | Z-0921-2008 |
Recall Event ID |
45947 |
510(K)Number | K952970 |
Product Classification |
Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
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Product | Stryker Modular Replacement System Curved Cemented Stem;
MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430 |
Code Information |
Catalog Number: 6485-3-313; Lot codes: LCDAS, LPF008, SCAN, TEC018B, TEC018C, TEC128, TEC129, TEC130, TEC131, TEC247, TEC247A, TEC247B, TECO18A, TECO18B. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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For Additional Information Contact | Rita 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 |
Action | On 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 Commerce | 803 total, all sizes |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JDI
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