Surgical Spinal Tap Device Recalled for Incorrect Laser Marking
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a laser marking error on a surgical instrument with no reported injuries or illnesses. This is classified as a minor labeling error rather than a structural or functional defect. FDA Class II classification with no reported adverse events supports a moderate severity level.
Plain-English summary
Medtronic Sofamor Danek USA, Inc. is recalling the CD HORIZON Spinal System Solera Awl Tip Tap surgical instrument (REF NAV2006K) due to incorrect laser marking. The recall affects 13 devices.
The affected devices were distributed to healthcare facilities in Florida, Colorado, Indiana, South Carolina, Texas, and Utah. Specific batch and lot number information is available from the FDA and the manufacturer.
Patients who may have received this device should contact their healthcare provider. Healthcare facilities should verify whether they received affected devices and contact Medtronic or the FDA for guidance.
The recalled product
- Product
- CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
- Manufacturer
- Medtronic Sofamor Danek USA, Inc
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958
- GTIN 00763000564087)
- Lot Numbers: 0011743681
- 0011734643
- 0011713764
- 0011722871
- 0011705200
Distribution
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