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U.S. Department of Health and Human Services

Class 2 Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mm

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 Class 2 Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mmsee related information
Date Initiated by FirmMay 05, 2005
Date PostedSeptember 29, 2010
Recall Status1 Terminated 3 on October 01, 2010
Recall NumberZ-2624-2010
Recall Event ID 50095
510(K)NumberK023087 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductGMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.
Code Information Catalog number: 6495-6-060; Lot code LZYOC1
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactRita Intorella
201-831-5825
Manufacturer Reason
for Recall		Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.
FDA Determined
Cause 2		Labeling mix-ups
ActionStryker issued Important Market WIthdrawal letters dated May 5, 2005 to customers and distributors. The letters identified the affected product, the labeling issue, and actions to be taken by the customer or distributor. Customers were instructed to identify and quarantine affected product, which will be reconciled and returned by the Stryker sales representative. Distributors were instructed to identify affected product, reconcile all product on an attached Product Accountability Form to be faxed to Stryker at 201 831-4825 within two days of receipt of the letter. The affected product was to be returned using the enclosed pre-paid mailing label. Contact the Stryker sales representative to re-order product that is being returned. Stryker can be contacted at 201 831-5825.
Quantity in Commerce5 units
DistributionNationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G
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 = KRO
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