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U.S. Department of Health and Human Services

Class 2 Device Recall BioSync Anatomic Cotton Wedge

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 Class 2 Device Recall BioSync Anatomic Cotton Wedgesee related information
Date Initiated by FirmApril 22, 2016
Create DateJune 14, 2016
Recall Status1 Terminated 3 on October 13, 2017
Recall NumberZ-1963-2016
Recall Event ID 74084
510(K)NumberK151256 
Product Classification Bone Wedge - Product Code PLF
ProductBioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Code Information Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information ContactBarry Dietz
800-933-7001 Ext. 76939
Manufacturer Reason
for Recall		Potential for polystyrene particulate presence.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.
Quantity in Commerce138 total products
DistributionDistributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = PLF
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