Z-2130-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- April 6, 2018
- Termination Date
- June 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Reason for Recall
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.
Distribution Pattern
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Code Information
(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955