Zimmer GmbH recalls Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213

Recall date

April 8, 2019

Source

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

Recall number

Z-1431-2019

FDA classification

Class II

Brand / firm

Zimmer GmbH

Sold / distributed

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Why it was recalled

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

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

What was recalled

Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213