FDA Medical Device Recalls (openFDA)
New Era Orthopaedics, LLc: Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- Recall number
- Z-2604-2018
- Recalling firm
- New Era Orthopaedics, LLc
- Product
- Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- Status
- Terminated
- Initiated
- 2017-02-13
- Posted
- not on file
- Terminated
- 2018-11-07
- 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.
- 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.
- Lot, serial or model codes
- 11125
- 510(k) numbers
- ["K141253","K150647"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3010760160
- Firm city
- Hummelstown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28