The Recall Desk
HighFDA (Devices)·Z-2604-2018·Announced 2018-08-15

New Era Orthopaedics Recalls Modera Pedicle Screw Shank Insertion Instrument

New Era Orthopaedics is recalling 6 shank insertion instruments for the Modera Modular Pedicle Screw System due to a laser weld failure reported after excessive force was applied.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in spine fusion procedures where a structural failure (weld failure) occurred, representing a risk of harm to patients, although no injuries are explicitly reported in the source text.

Plain-English summary

New Era Orthopaedics, LLC is conducting a retrospective recall of 6 pieces of the Modera Modular Pedicle Screw System Shank Insertion Instrument, model 3-107-07. The recall is being issued after the firm received a customer complaint stating that excessive forces were applied to the instrument, which resulted in a laser weld failure.

The affected instruments were distributed to two distributors located in Colorado and Texas. The source text does not specify the number of patients affected or report any injuries or illnesses associated with the use of these instruments.

Healthcare providers and patients who have used or possess this specific instrument should contact New Era Orthopaedics for further instructions on how to proceed with the recall.

The recalled product

Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Manufacturer
New Era Orthopaedics, LLc
Category
Medical Device — Orthopedic Instruments
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 11125

Distribution

Distributed in 2 states:

Related recalls

Same hazard · structural failure

See all →