Z-2604-2018 Class II Terminated
FDA device recall Z-2604-2018 was initiated by New Era Orthopaedics, LLc on February 13, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated November 7, 2018). Affected quantity: 6 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2018
- Initiation Date
- February 13, 2017
- Termination Date
- November 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 pieces
Product Description
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Reason for Recall
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.
Distribution Pattern
2 distributors in CO and TX.
Code Information
11125