Z-2396-2021Class II

TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as...

Name: Z-2396-2021 TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as...
Creator: DePuy Orthopaedics, Inc.
Published: 2021-08-10
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-08-10 / Terminated / root cause: software

FDA source

DePuy Orthopaedics, Inc. began a recall of TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the... on 2021-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2396-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-10
Posted: 2021-09-01
Terminated: 2023-05-17
Recalling firm: Depuy Orthopaedics Inc.
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
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: Depuy issued Urgent Medical Device Recall (Removal) Letter on 8/10/21. Letter states reson for recall, health risk and action take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. DO NOT USE THE PRODUCT. The surgical plan associated with the cases in Table 1 should not be used with conventional instruments. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of any affected devices or contact TruMatch Personalized Solutions Customer Support at 1-800-689-0746 / [email protected] between 7am and 7pm EST. 3. Review, complete, sign, and return the attached business response form (page 4 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2000415: 2021 - TruMatch Personalized Solutions 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the devices subject to this action). 5. If any of the subject lot has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. This medical device product recall has been reported to health authorities. We apologize for the inconvenience that this recall may cause and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Quantity in commerce: 2 cases (1 case)
Distribution: Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Product codes and lots: Lot numbers: 28206, 27983 GTIN: 10603295430773

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2396-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2394-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2395-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2396-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2397-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2398-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2399-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01
Z-2400-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01

Product code NJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)