The Recall Desk
HighFDA (Devices)·Z-2124-2018·Announced 2018-06-13

Orthofix Locking Screws Recalled Due to Failure to Engage Plates

Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System 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 with a confirmed functional defect (failure to engage plates) that poses a risk of harm during surgery, but the source text does not report 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 locking screws used in the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves 1,574 units of sterile, prescription-only locking screws in various sizes, ranging from 3.2mm x 10mm to 3.2mm x 50mm.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgical procedures. 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 and patients should check their inventory and surgical records for the specific lot numbers and UDI codes listed in the official recall notice. If you have used these specific locking screws, contact your healthcare provider for guidance on potential follow-up care or monitoring.

The recalled product

Product
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,574

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) (18056099646505) B1075433
  • b) (18056099646512) B1075434
  • c) (18056099646529) B1075844
  • d) (18056099646536) B1075432
  • e) (18056099646543) B1075436
  • f) (18056099646550) B1075826
  • g) (18056099646567) B1075837
  • h) (18056099646574) B1084804
  • i) (18056099646581) B1075835
  • j) (18056099646598) B1082233
  • k) (18056099646604) B1204272
  • B1075829
  • l) (18056099646611) B1204977
  • B1082245
  • m) (18056099646628) B1215471
  • B1204978
  • B1082247
  • n) (18056099646635) B1204979
  • B1084800
  • o) (18056099646642) B1204582

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 →

Related recalls

Same manufacturer · Orthofix, Inc

See all →

Same hazard · device failure

See all →