The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2119-2018·Announced 2018-06-13

Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates

Orthofix, Inc. is voluntarily recalling specific non-locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System 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 is classified as FDA Class II, and the source text describes a functional failure (screws not engaging plates) during surgery, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the text.

Plain-English summary

Orthofix, Inc. is conducting a voluntary recall of specific non-locking screws used in the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves 601 units of sterile, prescription-only screws in various sizes, ranging from 2.0mm x 8mm to 2.0mm x 30mm.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgical procedures. This defect could compromise the stability of the orthopedic fixation.

The affected products were 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. Healthcare providers and patients should contact Orthofix, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM…
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
601

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) (18056099645614) B1204542
  • B1101808
  • b) (18056099645621) B1204969
  • B1201169
  • B1075101
  • c) (18056099645638) B1204554
  • B1195701
  • B1075428
  • d) (18056099645645) B1204971
  • B1201176
  • B1075846
  • e) (18056099645652) B1195727
  • B1204266
  • B1075426
  • f) (18056099645669) B1204540
  • B1075429
  • g) (18056099645676) B1204541
  • B1075425
  • h) (18056099645683) B1204539
  • B1075177

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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