TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Summary
The FDA issued a Class II for TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended by DePuy Orthopaedics, Inc.. Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and.
Details
Source
Device Recall
External ID
Z-2395-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
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/Code Info: Lot number/ GTIN: 27929, 27855, 27667, 27591, 27521, 27332 GTIN 10603295430803
Quantity Affected: 6 cases (1/Cs)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-10
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DePuy Orthopaedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Orthopaedics, Inc. have FDA actions?
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2395-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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