Recall Z-1360-2016
Arthrex, Inc. · initiated January 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Reason for recall
Potential for a component contained in the Implant System to be non-sterile.
FDA-determined 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.
Details
- Recall number
- Z-1360-2016
- Initiated
- January 11, 2016
- Terminated
- July 24, 2019
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 117 devices
- 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.
- Recalling firm
- Arthrex, Inc., Naples, FL