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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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