Reported Aug 15, 2018 · Terminated
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
New Era Orthopaedics, 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: New Era Orthopaedics, LLc · 1214 Research Blvd Ste 1019 · Hummelstown, PA · 17036-9153
Is this the product you have?
- Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- Lot codes and dates
- 11125
- Amount recalled
- 6 pieces
Where it was sold
Why it was recalled
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
This product could cause temporary or reversible health problems — stop using it.
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