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U.S. Department of Health and Human Services

Class 3 Device Recall Orthopedic implant

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 Class 3 Recall
Orthopedic implant
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on February 03, 2010
Recall Number Z-2135-2008
Recall Event ID 48457
Premarket Notification
510(K) Numbers
K012655  K942340  K942341 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product 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.
Code Information Part number: COL-3140-S; Work order number/Lot: W46772 (W=work order, ###=sequential number); Expiration date: 2012-02 (Year/Month)
Recalling Firm/
Manufacturer
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9370
For Additional Information Contact Richard F. Snyder
503-627-9957 Ext. 1302
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 in Commerce 400 screws
Distribution Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ACUMED, INC.
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