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
This recall has been terminated (originally issued August 10, 2021).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- August 10, 2021
- Terminated
- May 17, 2023
- Recall Number
- Z-2399-2021
- Quantity
- 9 cases (1/cs)
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Lot / Code Info
Lot number/ GTIN: 28226, 28135, 27612, 27544, 27431, 27407, 26970 OUS: 27476, 27779 GTIN: 10603295384861;
Root Cause
Software Design Change
Action Taken
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.