Reported Jun 12, 2013 · Terminated
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been…
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?
- Straight Impactor - Dorado IBC
- Part NumberSI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices
- Lot codes and dates
- Lot number20856
- Amount recalled
- 10
Where it was sold
Why it was recalled
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
This product could cause temporary or reversible health problems — stop using it.
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