Synthes (USA) Products LLC recalls MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Tria…

Recall date

September 5, 2019

Source

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

Recall number

Z-0349-2020

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

AR

Why it was recalled

Modified outside of approved manufacturing process

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 INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle