Reported Jul 10, 2013 · Terminated
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used…
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?
- BASE
- S-LIFT Instrument Case Product UsageSystem cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine
- Lot codes and dates
- Lot/Serial Numbers7201.007 and 7201.007-1
- Amount recalled
- 12
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
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
This product could cause temporary or reversible health problems — stop using it.
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