FDA-Device2018-02-21Class II

Norian Drillable Inject

Synthes USA
Hazard

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.

Sold states
Nationwide Distribution.
Affected count
5 units
Manufactured in
1230 Wilson Dr, West Chester, PA, United States
Products
Norian Drillable Inject

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0618-2018

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