Synthes USA recalls Norian Drillable Inject

Recall date

August 10, 2017

Source

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

Recall number

Z-0617-2018

FDA classification

Class II

Brand / firm

Synthes USA

Sold / distributed

Nationwide Distribution.

Why it was recalled

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

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

What was recalled

Norian Drillable Inject