🔍 RecallPedia

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); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM X 30MM (002-D-27030); m) D 2.7MM X 32MM (002-D-27032); n) D 2.7MM X 34MM (002-D-27034); o) D 2.7MM X 36MM (002-D-27036); p) D 2.7MM X 38MM (002-D-27038); q) D 2.7MM X 40MM (002-D-27040)

Class I - Dangerous
🏥 Medical Devices Recalled: April 6, 2018 Orthofix Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    (UDI)/Lot: a) (8056099645782) B1075108; b) (18056099645799) B1075105 c) (18056099645805) B1071598, B1075178, B1075178; d) 18056099645812) B1069675, B1075431, B1075431; e) (18056099645829) B1071545, B1075435; f) (18056099645836) B1071540, B1075839; g) (18056099645843) B1068567, B1075827, B1075827; h) (18056099645850) B1082175, B1082175; i) (18056099645867) B1082237, B1068549, B1082237; j) (18056099645874) B1075060, B1082182; k) (18056099645881) B1068574, B1082236; l) (18056099645898) B1204990, B1071594, B1082232; m) (18056099645904) B1204993, B1071543, B1082222; n) (18056099645911) B1071542, B1195742, B1083645; o) (18056099645928) B1071539, B1083644, B1195708, B1083644; p) (18056099645935) B1204989, B1071541, B1089895; q) (18056099645942) B1069679, B1195752, B1069679, B1082235
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Orthofix, Inc
Reason for Recall:
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM X 30MM (002-D-27030); m) D 2.7MM X 32MM (002-D-27032); n) D 2.7MM X 34MM (002-D-27034); o) D 2.7MM X 36MM (002-D-27036); p) D 2.7MM X 38MM (002-D-27038); q) D 2.7MM X 40MM (002-D-27040)

Product Codes/Lot Numbers:

(UDI)/Lot: a) (8056099645782) B1075108; b) (18056099645799) B1075105 c) (18056099645805) B1071598, B1075178, B1075178; d) 18056099645812) B1069675, B1075431, B1075431; e) (18056099645829) B1071545, B1075435; f) (18056099645836) B1071540, B1075839; g) (18056099645843) B1068567, B1075827, B1075827; h) (18056099645850) B1082175, B1082175; i) (18056099645867) B1082237, B1068549, B1082237; j) (18056099645874) B1075060, B1082182; k) (18056099645881) B1068574, B1082236; l) (18056099645898) B1204990, B1071594, B1082232; m) (18056099645904) B1204993, B1071543, B1082222; n) (18056099645911) B1071542, B1195742, B1083645; o) (18056099645928) B1071539, B1083644, B1195708, B1083644; p) (18056099645935) B1204989, B1071541, B1089895; q) (18056099645942) B1069679, B1195752, B1069679, B1082235

Distribution:

Distributed in: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2121-2018

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