Reported Apr 28, 2021 · Terminated
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number…
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?
- Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product
- Number 5146-1208-N - Product Usageindicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof
- Lot codes and dates
GTIN 00191375013006Lot Number TM0126527
- Amount recalled
- 11 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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