Reported May 11, 2022 · Terminated
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials.…
restor3d 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: restor3d Inc. · 311 W Corporation St · Durham, NC · 27701-2409
Is this the product you have?
- Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
- Lot codes and dates
- Model6110-N01-KTS01
- Lot2022030005
- UDI00840097504506
- Amount recalled
- 14 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
This product could cause temporary or reversible health problems — stop using it.
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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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