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.
- Recall Initiated
- July 10, 2018
- Recall Number
- Z-1692-2020
- Quantity
- 28 (14 REF S200635 and 14 S200636)
- Firm Location
- Austin, TX
Reason for Recall
The retaining ring on the neck trials has a potential to fail interoperatively.
Distribution
Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Lot / Code Info
All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.
Root Cause
Process design
Action Taken
The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.