Rival Reduce Kit Plates recall
Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
Why was Rival Reduce Kit Plates recalled?
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
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?
UDI: 18056099648608, Lot: B1107421,
- Product
- Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
- Recalling firm
- Orthofix, Inc
- Quantity
- 50
- Distribution
- U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)