DePuy Orthopaedics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2397-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 10, 2021

Date Posted: September 8, 2021

Recall Number: Z-2397-2021

Event ID: 88522

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.

Status: Terminated

Product Quantity: 2 cases (1/cs)

Code Information:

Lot number/ GTIN: 27975, 27470 GTIN: 10603295384823

Distribution Pattern:

Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.

Voluntary or Mandated:

Voluntary: Firm initiated