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GMRS Extension Piece, 60 mm recallZ-2624-2010 · Stryker Howmedica Osteonics Corp. · initiated May 5, 2005

Terminated All recalls posted in September 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.

FDA root cause category: Labeling mix-ups

What the company is doing

Stryker 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.

Recall details

Recall number
Z-2624-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 5, 2005
Posted by the FDA
Sep 29, 2010
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
5 units
Product code
KRO
FDA submissions
K023087
Distribution
Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G

Product description

GMRS 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 (models, lots, serial numbers)

Catalog number: 6495-6-060; Lot code LZYOC1

Other devices under the same FDA submission

28 devices cleared under K023087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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