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DePuy Orthopaedics, Inc. Recall 88522

Description: TRUMATCH CT PIN GUIDE FEM R- 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: 420581

DePuy Orthopaedics, Inc. Recall 88522 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2396-2021
Event ID88522
Event DescriptionTRUMATCH CT PIN GUIDE FEM R- 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: 420581
Product TypeDevices
DistributionDistribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Quantity2 cases (1 case)
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 numbers: 28206, 27983 GTIN: 10603295430773
Center Classification Date20210901
Recall Initiation Date20210810
Recalling FirmDePuy Orthopaedics, Inc.
Initial Notification Letter
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