Encore Medical, Lp recalls Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

Recall date

September 19, 2018

Source

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

Recall number

Z-2090-2019

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US ( MS, NY, MO, OK, UT, AZ)

Why it was recalled

Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.

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

What was recalled

Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.