Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle recall
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Why was Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle recalled?
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
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?
Model number: 00-1300-0740, Lot number: M82791-1
- Product
- Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 24 units
- Distribution
- US Nationwide Distribution
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)