Recall Z-2135-2008 ยท HWC Screw, Fixation, Bone
Acumed LLC
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.
| Date | Sep 11, 2008 (initiated Jul 9, 2007) |
| Status | Terminated |
| Reason | Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly. |
| Root cause | Packaging process control |
| Action | The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957. |
| Quantity | 400 screws |
| Distribution | Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan. |
| FDA record | Open on fda.gov |