Medical device recalls Moderate risk

Encore Medical, Lp recalls MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Recall date
June 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2242-2016
FDA classification
Class II
Brand / firm
Encore Medical, Lp
Sold / distributed
CO, ID, TX

Why it was recalled

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

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

What was recalled

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

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