Reported Aug 16, 2023 · Ongoing
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medtronic Sofamor Danek USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA, Inc · 4340 Swinnea Rd · Memphis, TN · 38118-6603
Is this the product you have?
- CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
- Lot codes and dates
- 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
00117436810011734643001171376400117228710011705200
- Amount recalled
- 13 devices
Where it was sold
Why it was recalled
Incorrect Laser Marking - Solera Awl Tip Tap
This product could cause temporary or reversible health problems — stop using it.
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