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.
This recall has been terminated (originally issued January 11, 2016).
- Company
- Arthrex, Inc.
- Recall Initiated
- January 11, 2016
- Terminated
- July 24, 2019
- Recall Number
- Z-1360-2016
- Quantity
- 117 devices
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for a component contained in the Implant System to be non-sterile.
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.
Lot / Code Info
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Root Cause
Other
Action Taken
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.