Recall Z-0483-2014 ยท HWC Screw, Fixation, Bone
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arth
| Date | Dec 11, 2013 (initiated Oct 1, 2013) |
| Status | Terminated |
| Reason | Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. |
| Root cause | Labeling mix-ups |
| Action | Stryker sent notification letters/accountability forms via Fed Ex on October 1, 2013, with return receipt. to branches/agencies and hospital risk management, chief of orthopedics and surgeons. Domestic branch locations were notified by e-mail on 9/16/2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax the Product Recall Acknowledgement Form to 855-251-3635, return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430. Customers were ins |
| Quantity | Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894124 | OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS Osteonics Corp., Sep 11, 1989 |