Medical device recalls Moderate risk

Zimmer GmbH recalls CBS micro, countersink, cannulated, AO, Item Number ST503004541

Recall date
April 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1487-2019
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

CBS micro, countersink, cannulated, AO, Item Number ST503004541

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