FDA-Device2020-04-22Class II
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.
Encore Medical, LP
Hazard
The retaining ring on the neck trials has a potential to fail interoperatively.
Sold states
Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Affected count
28 (14 REF S200635 and 14 S200636)
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2020Don't want to check this manually?
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