Date Initiated by Firm |
July 09, 2007 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on February 03, 2010 |
Recall Number |
Z-2135-2008 |
Recall Event ID |
48457 |
510(K)Number |
K942340 K942341 K012655
|
Product Classification |
Smooth or threaded metallic bone fixation fastener - 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 OR 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 |
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 in Commerce |
400 screws |
Distribution |
Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = ACUMED, INC.
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