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)
This recall has been terminated (originally issued June 7, 2018).
- Company
- Orthofix, Inc
- Recall Initiated
- April 6, 2018
- Posted
- June 7, 2018
- Terminated
- June 30, 2021
- Recall Number
- Z-2130-2018
- Quantity
- 30
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Lot / Code Info
(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955
Root Cause
Device Design
Action Taken
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
More recalls by Orthofix, Inc
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-0102...
Jun 7, 2018
Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number):...
Jun 7, 2018
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-010...
Jun 7, 2018