Recall Z-2624-2010 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Stryker Howmedica Osteonics Corp.
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 whe
| Date | Sep 29, 2010 (initiated May 5, 2005) |
| Status | Terminated |
| Reason | Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece. |
| 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 |
| Quantity | 5 units |
| Distribution | Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023087 | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) Howmedica Osteonics Corp., Dec 16, 2002 |