RecallRadar

FDA Device recall Z-0273-2023

Unity Total Knee System

On 2022-11-30 the FDA classified a Class II recall of Unity Total Knee System by Corin, citing the internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0273-2023
ClassificationClass II
Statusterminated
Initiated2022-10-31
Published2022-11-30
Last updated2026-09-13 11:56 UTC
CompanyCorin
DistributionPR

Product

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

Reason

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

Identifiers

code_infoModel Number: 112.040.06; Lot Number: 504337

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.