Reported Aug 21, 2013 · Terminated
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of…
SpineFrontier, 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: SpineFrontier, Inc. · 500 Cummings Ctr Ste 3500 · Beverly, MA · 01915-6516
Is this the product you have?
- Invue Solid Driver, Tipped, AO
- Part Number11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral
- Lot codes and dates
- Lot Number
011836-0001011981-001
- Lot Number
- Amount recalled
- 9
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
Why it was recalled
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
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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