Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Nu
FDA device recall Z-2117-2018 · posted 2018-06-07 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 100
- Distribution
- U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
- Date initiated
- 2018-04-06
- Date posted
- 2018-06-07
- Date terminated
- 2021-06-30
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION (K142135) | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014-08-28 |