Modera Modular Pedicle Screw System Shank Insertion recall
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Why was Modera Modular Pedicle Screw System Shank Insertion recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
11125
- Product
- Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- Recalling firm
- New Era Orthopaedics, LLc
- Quantity
- 6 pieces
- Distribution
- 2 distributors in CO and TX.
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)