Device product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Z-2604-2018
Product summary
- Event
- Event 80499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 pieces
- Official record key
device-enforcement:Z-2604-2018
Official wording
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.
Code information: 11125
Distribution pattern: 2 distributors in CO and TX.
Derived failure modes
-
Unknown
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.