FDA recall Z-0618-2018

Product

Norian Drillable Inject

Reason for recall

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.

Distribution

Nationwide Distribution.

Key facts

Status

Terminated

Initiation date

2017-08-10

Report date

2018-02-21

Termination date

2018-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

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