Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm… recallZ-2042-2017 · Arthrex, Inc. · initiated Mar 24, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arthrex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some eyelets broke from SwiveLock Anchor on insertion.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 866-267-9138
Recall details
- Recall number
- Z-2042-2017
- Status
- Terminated
- Initiated by the company
- Mar 24, 2017
- Recalling firm
- Arthrex, Inc.
- Product code
- MAI
- FDA submissions
- K101823
- 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)
Product description
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Code information (models, lots, serial numbers)
Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-2323PSLMArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 76986).
- Z-2041-2017 · TerminatedAnthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
- Z-2043-2017 · TerminatedAnthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
- Z-2044-2017 · TerminatedAnthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
- Z-2045-2017 · TerminatedAnthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
- Z-2046-2017 · TerminatedAnthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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