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DePuy Orthopaedics, Inc. Recall 88522

Description: TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420915

DePuy Orthopaedics, Inc. Recall 88522 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2398-2021
Event ID88522
Event DescriptionTRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420915
Product TypeDevices
DistributionDistribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Quantity5 cases ( 1/cs)
Recall ReasonSoftware: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Device Classification20210908
Device Code InfoLot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854
Center Classification Date20210901
Recall Initiation Date20210810
Recalling FirmDePuy Orthopaedics, Inc.
Initial Notification Letter
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