| Class 2 Device Recall BioSync Anatomic Cotton Wedge | |
Date Initiated by Firm | April 22, 2016 |
Create Date | June 14, 2016 |
Recall Status1 |
Terminated 3 on October 13, 2017 |
Recall Number | Z-1963-2016 |
Recall Event ID |
74084 |
510(K)Number | K151256 |
Product Classification |
Bone Wedge - Product Code PLF
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Product | BioSync 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
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For Additional Information Contact | Barry Dietz 800-933-7001 Ext. 76939 |
Manufacturer Reason for Recall | Potential for polystyrene particulate presence. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | On 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 Commerce | 138 total products |
Distribution | Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI. |
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.
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510(K) Database | 510(K)s with Product Code = PLF
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