FDAClass IIAugust 16, 2023

CD HORIZON Spinal System Solera Awl Tip Tap recall

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Why was CD HORIZON Spinal System Solera Awl Tip Tap recalled?

Incorrect Laser Marking - Solera Awl Tip Tap

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

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

Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Recalling firm
Medtronic Sofamor Danek USA, Inc
Quantity
13 devices
Distribution
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Recall date
August 16, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls