Z-1692-2020 Class II Ongoing
FDA device recall Z-1692-2020 was initiated by Encore Medical, LP on Jul 10, 2018 and is designated Class II. Reason for recall: The retaining ring on the neck trials has a potential to fail interoperatively. The recall status is ongoing. Affected quantity: 28 (14 REF S200635 and 14 S200636).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2020
- Initiation Date
- Jul 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 (14 REF S200635 and 14 S200636)
Product Description
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
Reason for Recall
The retaining ring on the neck trials has a potential to fail interoperatively.
Distribution Pattern
Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Code Information
All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1692-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026