CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
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-2126-2018
- Quantity
- 24
- 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) (18056099647694) B1099067; b) (18056099647700) B1099061; c) (18056099647717) B1099063
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.
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