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DePuy Orthopaedics, Inc. Recall 91752

Description: Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

DePuy Orthopaedics, Inc. Recall 91752 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1263-2023
Event ID91752
Event DescriptionAttune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Quantity7 units
Recall ReasonThe 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.
Device Classification20230329
Device Code InfoGTIN: 10603295491095; Lot: JP6452
Center Classification Date20230317
Recall Initiation Date20230215
Recalling FirmDePuy Orthopaedics, Inc.
Initial Notification Letter
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