FDA recall Z-1692-2020

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.

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.

Key facts

Status

Ongoing

Initiation date

2018-07-10

Report date

2020-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2020