Z-1360-2016 Class II Terminated
FDA device recall Z-1360-2016 was initiated by Arthrex, Inc. on Jan 11, 2016 and is designated Class II. Reason for recall: Potential for a component contained in the Implant System to be non-sterile. The recall status is terminated (terminated Jul 24, 2019). Affected quantity: 117 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2016
- Initiation Date
- Jan 11, 2016
- Termination Date
- Jul 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117 devices
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.
Reason for Recall
Potential for a component contained in the Implant System to be non-sterile.
Distribution Pattern
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.
Code Information
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1360-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026