| Class 2 Device Recall Arthrex SwiveLock Anchors | |
Date Initiated by Firm | March 24, 2017 |
Create Date | May 05, 2017 |
Recall Status1 |
Terminated 3 on November 04, 2019 |
Recall Number | Z-2043-2017 |
Recall Event ID |
76986 |
510(K)Number | K101823 |
Product Classification |
Fastener, fixation, biodegradable, soft tissue - Product Code MAI
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Product | Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching |
Code Information |
Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018 |
Recalling Firm/ Manufacturer |
Arthrex, Inc. 1370 Creekside Blvd Naples FL 34108-1945
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Manufacturer Reason for Recall | Some eyelets broke from SwiveLock Anchor on insertion. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138 |
Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico
Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD) |
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 = MAI
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