🔍 RecallPedia

Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) D 2.0MM X 20MM (002-E-20020); h) D 2.0MM X 22MM (002-E-20022); i) D 2.0MM X 24MM (002-E-20024); j) D 2.0MM X 26MM (002-E-20026); k) D 2.0MM X 28MM (002-E-20028); l) D 2.0MM X 30MM (002-E-20030)

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) (18056099646161)B1204974, B1089899, B1201171, B1201171; b) (18056099646178) B1195696, B1204268, B1083839; c) (18056099646185) B1215486, B1201172, B1201172, B1204281, B1083845; d) (18056099646192) B1215489, B1204975, B1083855, B1201173, B1201173; e) (18056099646208) B1215482, B1204585, B1195748, B1089887; f) (18056099646215) B1215488, B1204559, B1083856; g) (18056099646222) B1215483, B1204558, B1083854; h) (18056099646239) B1215490, B1204277, B1195721, B1083849; i) (18056099646246) B1215484, B1204279, B1195703, B1089890; j) (18056099646253) B1215491, B1204283, B1195720, B1083648; k) (18056099646260) B1215485, B1089879, B1201174, B1204267, B1204267; l) (18056099646277) B1215487, B1204284, B1195751, B1083857
  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:

Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) D 2.0MM X 20MM (002-E-20020); h) D 2.0MM X 22MM (002-E-20022); i) D 2.0MM X 24MM (002-E-20024); j) D 2.0MM X 26MM (002-E-20026); k) D 2.0MM X 28MM (002-E-20028); l) D 2.0MM X 30MM (002-E-20030)

Product Codes/Lot Numbers:

(UDI)/Lot: a) (18056099646161)B1204974, B1089899, B1201171, B1201171; b) (18056099646178) B1195696, B1204268, B1083839; c) (18056099646185) B1215486, B1201172, B1201172, B1204281, B1083845; d) (18056099646192) B1215489, B1204975, B1083855, B1201173, B1201173; e) (18056099646208) B1215482, B1204585, B1195748, B1089887; f) (18056099646215) B1215488, B1204559, B1083856; g) (18056099646222) B1215483, B1204558, B1083854; h) (18056099646239) B1215490, B1204277, B1195721, B1083849; i) (18056099646246) B1215484, B1204279, B1195703, B1089890; j) (18056099646253) B1215491, B1204283, B1195720, B1083648; k) (18056099646260) B1215485, B1089879, B1201174, B1204267, B1204267; l) (18056099646277) B1215487, B1204284, B1195751, B1083857

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-2120-2018

Related Recalls