NA 201.670Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982142351), received between Apr 19, 2022 and Jan 4, 2023 — classified as 3 injuries.

2 other recalls cover devices cleared under the same FDA submission (K001941, K030310, K040588, K112583); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE PATIENT NOTICED BLISTERS ON THEIR FOOT. THE PATIENT HAD ALSO BEEN EXPERIENCING SWELLING AND FOOT DISCOLORATION FOR THE PAST TWO YEARS. IN (B)(6) 2019 THE PATIENT UNDERWENT AN UNKNOWN FOOT FUSION PROCEDURE, DURING WHICH THE SCREW IN QUESTION WAS IMPLANTED. THE PATIENT HAS A KNOWN NICKEL ALLERGY, AND IT IS SUSPECTED THAT THE BLISTERS AND SWELLING ARE RELATED TO THE COMPOSITION OF THE IMPLANTED SCREW. THIS REPORT IS FOR A 2.4MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Skin Discoloration; Swelling/ Edema

  MAUDE report 16095307 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 11 OF 12 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SELF-TAPPING 40MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14148256 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 9 OF 12 FOR PC-(B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SELF-TAPPING 40MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147992 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001941, K030310, K040588, K112583. One submission often covers many models, so check the product and lot details in each record.

• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0406-2014 · Jul 30, 2013 · Terminated
  Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.