Orthofix Rival Reduce Kit Locking Screws Recalled for Failure to Engage Plates
Orthofix is voluntarily recalling Rival Reduce Kit locking screws because they failed to properly engage plates during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to perform its intended function during surgery, creating a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM and D 2.7MM, sterile, prescription-only devices. The recall involves 50 units of the Rival Reduce Fracture Plating System and Rival View Plating System.
The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. The affected products are identified by Part Number 000-K-011C and specific UDI codes.
The devices were distributed to consignees in New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Washington D.C., Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma. Healthcare providers and patients should contact Orthofix for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
- Manufacturer
- Orthofix, Inc
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 18056099648592
- B1115657
- B1107222
- B1107223
Distribution
Part of a larger recall action
This product is one of 20 recalled by Orthofix, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Orthofix, Inc
See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
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- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
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