Orthofix Recalls TN Plates Due to Screw Engagement Failure
Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the 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 defect where locking screws failed to engage plates during surgery. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the TN Plate, Sterile, Rx Only, which is part of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall affects 24 units in Small, Medium, and Large sizes.
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 fracture fixation.
The affected products were distributed to consignees in New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, the District of Columbia, Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma. Healthcare providers should stop using the affected lots and contact Orthofix for instructions on return or replacement.
The recalled product
- Product
- TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
- Manufacturer
- Orthofix, Inc
- Affected units
- 24
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) (18056099647663) B1099060
- b) (18056099647670) B1099062
- c) (18056099647687) B1099066
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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See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
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- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
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