Medical device recalls Moderate risk

Biomet Microfixation, LLC recalls Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.

Recall date
August 6, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0136-2016
FDA classification
Class II
Brand / firm
Biomet Microfixation, LLC
Sold / distributed
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.

Why it was recalled

The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

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

What was recalled

Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.

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