Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Hazard
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.
What You Should Do
Remedy
On February 13, 2017, the firm emailed its distributors to notify them that their Rev. A devices would be replaced with Rev. B devices, and asked the distributors to mail back the Rev. A devices.
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Products
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- Brand
- New Era Orthopaedics, LLc
- UPC
- 11125
Units Affected
6 pieces