The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2121-2018·Announced 2018-06-13

Orthofix Recalls Non-Locking Screws for Improper Plate Engagement

Orthofix, Inc. is voluntarily recalling specific non-locking screws used in fracture plating systems 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The defect involves a structural failure of the medical device (screws not engaging plates) during surgery, which poses a significant risk of harm to patients, fitting the 'Severe' criteria for structural defects or significant injury risks.

Plain-English summary

Orthofix, Inc. is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves 935 units of Non-Locking Screws, specifically the D 2.7MM diameter sizes ranging from 8MM to 40MM in length. These sterile, prescription-only devices are manufactured by Orthofix, Inc. and labeled with ORTHOFIX S.r.r. Italy.

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 units 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 part numbers and lot numbers listed in the official recall notice. If you have used these specific screws, contact your healthcare provider to discuss the potential impact on your surgical outcome. Orthofix, Inc. is the recalling firm responsible for managing this Class II recall.

The recalled product

Product
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016)…
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
935

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) (8056099645782) B1075108
  • b) (18056099645799) B1075105 c) (18056099645805) B1071598
  • B1075178
  • d) 18056099645812) B1069675
  • B1075431
  • e) (18056099645829) B1071545
  • B1075435
  • f) (18056099645836) B1071540
  • B1075839
  • g) (18056099645843) B1068567
  • B1075827
  • h) (18056099645850) B1082175
  • B1082175
  • i) (18056099645867) B1082237
  • B1068549
  • B1082237
  • j) (18056099645874) B1075060
  • B1082182
  • k) (18056099645881) B1068574
  • B1082236

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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