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Recall Observatory FDA recall evidence

Device product

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Z-0273-2023

October 31, 2022

Class II

Product summary

Firm
Corin Ltd
Event
Event 91039
Status
Terminated
Classification
Class II
Quantity
4 devices
Official record key
device-enforcement:Z-0273-2023

Official wording

Reason: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Code information: Model Number: 112.040.06; Lot Number: 504337

Distribution pattern: Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.