Orthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
Orthofix, Inc. is voluntarily recalling specific Non-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 defect where the device failed to perform its intended function (engaging plates) during surgery. This represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of 1,206 units of Non-Locking Screws, Sterile, Rx Only. The affected products are part of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall covers specific sizes ranging from 3.2mm x 10mm to 3.2mm x 50mm, identified by various part numbers and lot codes.
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 units were distributed to consignees in multiple U.S. states, including 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 and facilities should check their inventory for the specific part numbers and lot codes listed in the recall notice. If the affected screws are found, they should be removed from use and returned to Orthofix, Inc. according to the firm's instructions. Patients who have had these specific screws implanted should contact their healthcare provider to discuss the findings and any necessary follow-up care.
The recalled product
- Product
- Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM…
- Manufacturer
- Orthofix, Inc
- Affected units
- 1,206
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 (20)
- (UDI)/Lot: a) (18056099645959) B1082246
- b) (18056099645966) B1075836
- c) (18056099645973) B1084806
- d) (18056099645980) B1089892
- e) (18056099645997) B1075845
- f) (18056099646000) B1084797
- g) (18056099646017) B1084792
- h) (18056099646024) B1084799
- i) (18056099646031) B1083858
- j) (18056099646048) B1083859
- k) (18056099646055) B1089891
- B1195735
- l) (18056099646062) B1195736
- B1089882
- m)(18056099646079) B1204992
- B1083850
- n) (18056099646086) B1083848
- B1195699
- o) (18056099646093) B1195732
- B1089896
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
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
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
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- HighOrthofix Recalls Connector System Set Screws Due to Size Discrepancies
FDA (Devices) · 2018-04-18
- ModerateOrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error
FDA (Devices) · 2015-09-30
- ModerateOrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error
FDA (Devices) · 2014-02-12
- HighOrtho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect
FDA (Devices) · 2015-10-14
- ModerateOrtho Solutions Recalls Mislabeled 35mm Non-Locking Orthopedic Screws
FDA (Devices) · 2016-09-28
- HighWright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging
FDA (Devices) · 2022-03-23