Z-2624-2010

GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick...

Name: Z-2624-2010 GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-05-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-05-05 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is... on 2005-05-05. The reason FDA records is "Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2624-2010
Status: Terminated
Initiated: 2005-05-05
Posted: 2010-09-29
Terminated: 2010-10-01
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 5 units
Distribution: Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G
Product codes and lots: Catalog number: 6495-6-060; Lot code LZYOC1

Product code KRO

K023087Class IIGlobal Modular Replacement System (Gmrs)Howmedica Osteonics Corp. / cleared 2002-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)