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U.S. Department of Health and Human Services

Class 2 Device Recall Biotrak Resorbable Fixation System

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 Class 2 Recall
Biotrak Resorbable Fixation System
see related information
Date Posted October 23, 2009
Recall Status1 Terminated on November 06, 2010
Recall Number Z-0073-2010
Recall Event ID 53163
Premarket Notification
510(K) Number
K061763 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.
Code Information Lot W67385, Model #30170320-S, expiration 8/2010 (two side labels correctly state 30170320-S, Lot W67385; top label may incorrectly state 30170060-S, lot W67391).
Recalling Firm/
Manufacturer
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9432
Manufacturer Reason
for Recall
Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385).
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Urgent Notice: Device Recall Letters dated August 21, 2009 were sent to all consignees advising of the issue and and required action. Customers are to identify and quarantine the product having the affected lot code(s). Customers are to also return all product from the specified lot(s) to Acumed immediately. If product was further distributed, then those consignees should be notified of the recall and return of the product(s) should be requested. Questions should be directed to Acumed Customer Service at 1-888-627-9957.
Quantity in Commerce 125
Distribution Worldwide Distribution -- USA and South Africa.
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 = ARC SURGICAL LLC.
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