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U.S. Department of Health and Human Services

Class 3 Device Recall AcuLoc Distal Radius Plate

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 Class 3 Recall
AcuLoc Distal Radius Plate
see related information
Date Posted August 28, 2008
Recall Status1 Terminated on February 03, 2010
Recall Number Z-2153-2008
Recall Event ID 48466
Premarket Notification
510(K) Number
K012655 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
Code Information Lot: W4800; Expiration date: 2012-02
Recalling Firm/
Manufacturer
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9370
For Additional Information Contact Mr. Richard Snyder
503-627-9957 Ext. 293
Manufacturer Reason
for Recall
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed.
Quantity in Commerce 51 pieces
Distribution Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.
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 = HRS and Original Applicant = ACUMED, INC.
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