Orthofix Rival View Kit Locking Screws Recalled for Failure to Engage Plates
Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.
What this means for you
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 defect (failure to engage) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, Part Number: 000-K-009C. The recall covers 100 units 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.
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 UDI 18056099648578 and lot numbers B1094193, B1104809, and B1107372.
Healthcare providers and facilities should stop using the affected screws and contact Orthofix, Inc. for instructions on return or replacement. Patients who have had these screws implanted should consult their healthcare provider to determine if further evaluation is necessary.
The recalled product
- Product
- 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 Number: 000-K-009C
- Manufacturer
- Orthofix, Inc
- Hazard
- Affected units
- 100
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: 18056099648578
- Lot: B1094193
- B1104809
- B1107372
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
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