Z-2397-2021 Class II Terminated
FDA device recall Z-2397-2021 was initiated by DePuy Orthopaedics, Inc. on August 10, 2021 and is designated Class II. Reason for recall: Software: 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 la… The recall status is terminated (terminated May 17, 2023). Affected quantity: 2 cases (1/cs).
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- August 10, 2021
- Termination Date
- May 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 cases (1/cs)
Product Description
TRUMATCH CT FEM CUT TIB PIN 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: 420907
Reason for Recall
Software: 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.
Distribution Pattern
Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Code Information
Lot number/ GTIN: 27975, 27470 GTIN: 10603295384823