DePuy Orthopaedics, Inc.: 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.

Agency Publication Date: September 1, 2021

Affected Products

Product: 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

Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854

Lot Numbers:

number

Product: TRUMATCH CT CUT GUIDE KIT 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: 420916

Lot number/ GTIN: 28226, 28135, 27612, 27544, 27431, 27407, 26970 OUS: 27476, 27779 GTIN: 10603295384861;

Lot Numbers:

number

Product: TRUMATCH CT CUT GUIDE FEM 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: 420917

Lot number/ GTIN: 27958 10603295384878

Lot Numbers:

number

Product: TRUMATCH CT PIN 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: 420578

Lot Numbers: 27932 , 27806, 27515, 27466, GTIN: 10603295430797

Lot Numbers:

Numbers

Product: TRUMATCH CT PIN GUIDE KIT 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: 420579

Lot number/ GTIN: 27929, 27855, 27667, 27591, 27521, 27332 GTIN 10603295430803

Lot Numbers:

number

Product: 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

Lot numbers: 28206, 27983 GTIN: 10603295430773

Lot Numbers:

numbers

Product: 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

Lot number/ GTIN: 27975, 27470 GTIN: 10603295384823

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88522

Status: Resolved

Manufacturer: DePuy Orthopaedics, Inc.

Manufactured In: United States

Units Affected: 7 products (4 cases (1/case); 6 cases (1/Cs); 2 cases (1 case); 2 cases (1/cs); 5 cases ( 1/cs); 9 cases (1/cs); 1 cs (1/cs))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854

Lot Numbers:

number

Lot number/ GTIN: 28226, 28135, 27612, 27544, 27431, 27407, 26970 OUS: 27476, 27779 GTIN: 10603295384861;

Lot Numbers:

number

Lot number/ GTIN: 27958 10603295384878

Lot Numbers:

number

Lot Numbers: 27932 , 27806, 27515, 27466, GTIN: 10603295430797

Lot Numbers:

Numbers

Lot number/ GTIN: 27929, 27855, 27667, 27591, 27521, 27332 GTIN 10603295430803

Lot Numbers:

number

Lot numbers: 28206, 27983 GTIN: 10603295430773

Lot Numbers:

numbers

Lot number/ GTIN: 27975, 27470 GTIN: 10603295384823

Lot Numbers:

number