||September 11, 2008
||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.
||Part number: COL-3140-S; Work order number/Lot: W46772 (W=work order, ###=sequential number); Expiration date: 2012-02 (Year/Month)
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9370
|For Additional Information Contact
||Richard F. Snyder
503-627-9957 Ext. 1302
|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.
||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 in Commerce
||Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.