Recall Z-1618-2012 ยท HTO Reamer
Stryker Howmedica Osteonics Corp.
Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Sphe
| Date | May 17, 2012 (initiated Dec 23, 2011) |
| Status | Terminated |
| Reason | A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field. |
| Root cause | Device Design |
| Action | Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies th |
| Quantity | 134 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.