Use caution Medical device recall · FDA · Published August 10, 2021

DePuy TRUMATCH CT Cut Guide Kit L: Software error risks limb misalignment during surgery

DePuy recalls TRUMATCH CT Cut Guide Kit L patient-specific surgical instruments due to a software error that may cause hip, knee or ankle misalignment during joint replacement surgery. Affected units have specific part numbers and GTINs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2398-2021Medical device DePuy ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994

✎ GovInfoNow plain-language explainer

DePuy is recalling TRUMATCH CT Cut Guide Kit L surgical instruments because a software error could cause misalignment of limbs during hip, knee or ankle joint replacement surgery. This risks improper surgical outcomes and potential complications. Read more at govinfonow.com/recall/61978-depuy-trumatch-ct-cut-guide-kit-l-software-error-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/61978-depuy-trumatch-ct-cut-guide-kit-l-software-error-risks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2398-2021

Cite this page

“DePuy TRUMATCH CT Cut Guide Kit L: Software error risks limb misalignment during surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61978-depuy-trumatch-ct-cut-guide-kit-l-software-error-risks. Based on FDA recall #Z-2398-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2021%22&limit=1).

The FDA announced on August 10, 2021, that DePuy Orthopaedics, Inc. is voluntarily recalling the TRUMATCH CT CUT GUIDE KIT L due to a software coding error. This defect may cause limb malalignment during surgery by misaligning required hip, knee, and ankle images.

How to tell if you have it

TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments
UPC: 10603295384854

The hazard

A coding error in the Fast3D Segmentation software may cause the three images required of the hip, knee, and ankle to not be aligned. This misalignment can result in anatomic landmark locations that potentially cause limb malalignment.

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Recent recalls include the ATTUNE Knee Component recall dated March 12, 2024, and the Attune Revision Limb Preservation Tibial Insert recall dated February 15, 2023. Other recent recalls of similar products include the restor3d Kinos Axiom Ankle Implant Recall (July 27, 2026), Think Surgical TMINI Tracking Arrays (May 8, 2026), and Da Vinci Surgical System (November 7, 2025).

How to tell if you have this one

Check for part numbers 420915 or GTINs 28289, 28247, 27876, 27432, 27613. These instruments were sold with the OUS (outside the U.S.) designation.

Brand
DePuy
Product
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

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

Recall number	Product, codes & lots	Quantity
Z-2394-2021	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	4 cases (1/case)
Z-2395-2021	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	6 cases (1/Cs)
Z-2396-2021	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	2 cases (1 case)
Z-2397-2021	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	2 cases (1/cs)
Z-2398-2021	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	5 cases ( 1/cs)
Z-2399-2021	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;	9 cases (1/cs)
Z-2400-2021	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	1 cs (1/cs)

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your instrument's part number or GTIN to confirm if it's affected by this recall.
Contact Manufacturer
Reach out to DePuy Orthopaedics for guidance on next steps if you have the recalled instruments.

Where it went and when

Where it was distributed

Distributed in 10 states.

FDA distribution: “Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Washington.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Aug 10, 2021Firm started the recall
Sep 1, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
May 17, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61978-depuy-trumatch-ct-cut-guide-kit-l-software-error-risks">DePuy TRUMATCH CT Cut Guide Kit L: Software error risks limb misalignment during surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2398-2021 (August 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2398-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.