TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific recall: Nitrosamine Impurity
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in…
Why was TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854
- Product
- TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 5 cases ( 1/cs)
- Distribution
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)