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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Replacement System (MRS) Cemented Stems

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  Class 2 Device Recall Modular Replacement System (MRS) Cemented Stems see related information
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
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
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
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 = KRO and Original Applicant = HOWMEDICA OSTEONICS CORP
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