Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that failed to engage during surgery, posing a significant risk of injury or device failure.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves specific sterile box plates in 18MM, 22MM, and 30MM sizes manufactured by Orthofix, Inc.
The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This defect could compromise the stability of the orthopedic fixation.
The affected products 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, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
- Manufacturer
- Orthofix, Inc
- Affected units
- 54
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 (3)
- (UDI)/Lot: a) (18056099647854) B1102026
- b) (18056099647878) B1101930
- c) (18056099647892) B1098806
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 →- SevereOrthofix Recalls Non-Locking Screws for Improper Plate Engagement
FDA (Devices) · 2018-06-13
- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
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
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
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