Reported Jun 5, 2013 · Terminated
14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7…
Spinal Solutions, 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: Spinal Solutions, LLC · 26157 Jefferson Ave · Murrieta, CA · 92562-9561
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
14 | 14 x 11 x 6mm 7 deg |
14 | x 11 x 7mm 7 deg |
14 | x 11 x 8mm 7 deg |
14 | x 11 x 9mm 7 deg |
14 | x 11 x 10mm 7 deg |
14 | x 11 x 11mm 7 deg |
- Lot codes and dates
- Item # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712
- Amount recalled
- 35 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
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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