CLASS II ONGOING Device recall · Reported 16 Aug 2023 · FDA Enforcement Report
CD Horizon Spinal System Solera Awl Tip Tap recalled
Medtronic Sofamor Danek USA is recalling CD Horizon Spinal System Solera Awl Tip Tap, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2363-2023
- FDA event ID
- 92749
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2023
- FDA classified
- 9 Aug 2023
- Reported
- 16 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 12 Jul 2023 | Recall initiated by company | |
| 9 Aug 2023 | Classified by FDA | +28 days |
| 16 Aug 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Laser Marking - Solera Awl Tip Tap
Product as listed by the FDA
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Where it was distributed
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Questions about this recall
Why was it recalled?
Incorrect Laser Marking - Solera Awl Tip Tap
Which lots 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
Where was it sold?
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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