Djosurgical Linear Neck Trials with Spring Sides recalled over sterility concerns

Recall date

July 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Encore Medical, LP recalls djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trial…

Recall number

Z-1692-2020

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

Why it was recalled

The retaining ring on the neck trials has a potential to fail interoperatively.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.