CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Summary
The FDA issued a Class II for CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K by Medtronic Sofamor Danek USA, Inc. Reason: Incorrect Laser Marking - Solera Awl Tip Tap.
Details
Source
Device Recall
External ID
Z-2363-2023
Action Date
2023-08-16
Status
Ongoing
Category
device
Product Description
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Lot/Code Info: SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200
Quantity Affected: 13 devices
Reason for Recall
Incorrect Laser Marking - Solera Awl Tip Tap
Distribution
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-12
Company
Memphis, TN
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 208 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Sofamor Danek USA, Inc has 60 FDA actions in our database, including 37 recalls and 23 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 (Medtronic Sofamor Danek USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Sofamor Danek USA, Inc have FDA actions?
Medtronic Sofamor Danek USA, Inc has 60 FDA actions in our database, including 37 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2363-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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