Recall Z-2604-2018 ยท MNI Orthosis, Spinal Pedicle Fixation
New Era Orthopaedics, LLc
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
| Date | Feb 13, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 6 pieces |
| Distribution | 2 distributors in CO and TX. |
| FDA record | Open on fda.gov |