Reported Jul 15, 2020 · Terminated
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the…
TeDan Surgical Innovations LLC
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: TeDan Surgical Innovations LLC · 12615 W Airport Blvd Ste 200 · Sugar Land, TX · 77478-6203
Is this the product you have?
- PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX -
- Product Usageintended to be used for distraction in the anterior approach to the cervical spine
- Lot codes and dates
- Product CodeDS-0012
- UDI Number00851797006443
- Lot Number2018021901 2018061101
- Amount recalled
- 1965 screws (packaged into 393 boxes) - [5 screws per box]
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Lack of pouch seal. Product is labelled as sterile.
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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