Hummelstown, PA, United States
New Era Orthopaedics, LLc recalls
1 recall recorded since 2018, most recently on 13 February 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 February 2017
- Terminated
- 7 November 2018
- 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.
- Distribution
- 2 distributors in CO and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2604-2018
- Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.