| Class 2 Device Recall Modular Replacement System (MRS) Cemented Stems | |
Date Initiated by Firm | January 30, 2009 |
Date Posted | April 17, 2009 |
Recall Status1 |
Terminated 3 on April 08, 2010 |
Recall Number | Z-1251-2009 |
Recall Event ID |
51212 |
510(K)Number | K040749 |
Product Classification |
Knee Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
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Product | Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319.
The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
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For Additional Information Contact | Colleen O'Meara 201-831-5970 |
Manufacturer Reason for Recall | Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components. |
FDA Determined Cause 2 | Labeling False and Misleading |
Action | Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales rep if they weren't not contacted by them. Questions should be directed to Colleen O'Meara at 201-831-5970. |
Quantity in Commerce | 1161 units |
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 = KRO
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