Recall Z-2604-2018— New Era Orthopaedics, LLc
Class II · Terminated
Class II FDA medical device recall by New Era Orthopaedics, LLc, initiated 2017-02-13, terminated 2018-11-07. It names 2 FDA 510(k) clearances: K150647, K141253. Product: Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07. 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..
- Recalling firm
- New Era Orthopaedics, LLc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-13
- Terminated
- 2018-11-07
- Firm location
- Hummelstown, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K150647 — Polyscrew Pedicle Screw System
- K141253 — NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.