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DePuy Orthopaedics, Inc. Recall: Attune Revision Limb Preservation System (LPS) Tibial Ins

DePuy Orthopaedics, Inc. Recall: Attune Revision Limb Preservation System (LPS) Tibial Ins is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DePuy Orthopaedics, Inc.; Product: Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118; Reason for recall

Recalling firmDePuy Orthopaedics, Inc.
ProductAttune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Reason for recallThe subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Recall initiated20230215
Recall numberZ-1263-2023
Categorydevice
StateIN
CountryUnited States

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