Integra External Fixation System Rocker Bottom recall: Mold
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of…
Why was Integra External Fixation System Rocker Bottom recalled?
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
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?
Lot # PN625.
- Product
- Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 27 units
- Distribution
- Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
- Recall date
- August 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)