Z-1692-2020 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type
Devices
Report Date
April 22, 2020
Initiation Date
July 10, 2018
Termination Date
N/A
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.