FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: 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
- Recall number
- Z-2400-2021
- Recalling firm
- DePuy Orthopaedics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-08-10
- Posted
- not on file
- Terminated
- 2023-05-17
- Reason
- 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
- 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 / trumatchsupport@its.jnj.com between 7am and 7pm EST. 3. Review, complete, sign, and return the attached business response form (page 4 of this letter) to OneMD-Field-Actions@its.jnj.com 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
- 1 cs (1/cs)
- Distribution
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- Lot, serial or model codes
- Lot number/ GTIN: 27958 10603295384878
- 510(k) numbers
- not on file
- PMA numbers
- ["P830055"]
- Product code
- NJL
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28