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Recall Observatory FDA recall evidence

Device product

Norian Drillable Inject

Z-0618-2018

August 10, 2017

Class II

Product summary

Firm
Synthes USA
Event
Event 79043
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-0618-2018

Official wording

Reason: 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.

Code information: Product Number: 07.704.010S Lot Number: DSE0733

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.