FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA, Inc: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
- Recall number
- Z-2363-2023
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Product
- CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
- Status
- Open, Classified
- Initiated
- 2023-07-12
- Posted
- 2023-08-09
- Terminated
- not on file
- Reason
- Incorrect Laser Marking - Solera Awl Tip Tap
- Root cause
- Under Investigation by firm
- Action
- Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignee on 07/12/2023 by UPS 2nd day mail. The notice explained the problem with the product, risk, and requested the following actions be taken immediately: " Identify and quarantine any impacted product(s). Return all impacted product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."
- Quantity
- 13 devices
- Distribution
- US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K140454"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3003120897
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28