Arthrex Deltoid Ligament Reconstruction Implant System recallZ-1360-2016 · Arthrex, Inc. · initiated Jan 11, 2016
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
Potential for a component contained in the Implant System to be non-sterile.
FDA root cause category: Other
What the company is doing
On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information.
Recall details
- Recall number
- Z-1360-2016
- Status
- Terminated
- Initiated by the company
- Jan 11, 2016
- Recalling firm
- Arthrex, Inc.
- Quantity
- 117 devices
- Product code
- HRS
- FDA submissions
- K031666
- Distribution
- Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
Product description
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Code information (models, lots, serial numbers)
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-8918CPArthrex, Inc. · Screw, fixation, bone1 recall1 report
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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