Device product
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.
Z-1692-2020
Product summary
- Event
- Event 85211
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 (14 REF S200635 and 14 S200636)
- Official record key
device-enforcement:Z-1692-2020
Official wording
Reason: The retaining ring on the neck trials has a potential to fail interoperatively.
Code information: All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.
Distribution pattern: Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The retaining ring on the neck trials has a potential to fail interoperatively.