The Recall Desk
HighFDA (Devices)·Z-2123-2018·Announced 2018-06-13

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.

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 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 (002-D-32
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implants
Hazard
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

Distributed in 19 states:

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 →

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