Biomet recalls Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235

Recall date

May 1, 2020

Source

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

Recall number

Z-2362-2020

FDA classification

Class II

Brand / firm

Biomet

Sold / distributed

Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

Why it was recalled

Device and tray that houses the device did not pass steam sterilization process validation testing

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

What was recalled

Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235