Biomet Microfixation, LLC recalls Thinflap System 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-0137-2016

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

Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.