NA 208.408Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982149152), received between Jan 3, 2018 and Jan 3, 2018 — classified as 1 injury.

7 other recalls cover devices cleared under the same FDA submission (K021932, K161616); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL AND REVISION SURGERY PERFORMED ON (B)(6) 2017, DUE TO NON-UNION. THE PATIENT ORIGINALLY HAD AN ANKLE FUSION PERFORMED ON AN UNKNOWN DATE AND WAS IMPLANTED WITH ONE (1) 6.5 MM CANCELLOUS BONE SCREW 16 MM THREAD FOR 45 MM, TWO (2) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 50 MM, THREE (3) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 55 MM AND ONE (1) CANNULATED CANCELLOUS SCREW 16 MM THREAD 65 MM. ON (B)(6) 2017, THE PATIENT WAS DISCOVERED TO HAVE A NON-UNION AND ALL THE ORIGINALLY IMPLANTED CONSTRUCTS WERE REMOVED FULLY INTACT. THE PATIENT WAS REVISED TO TWO (2) ONE-THIRD TUBULAR PLATES AND THREE (3) CORTEX SCREWS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7160643 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021932, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-2156-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, s
• Z-2153-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment
• Z-2152-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment
• Z-2157-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large b
• Z-2155-2016 · Feb 16, 2016 · Terminated
  4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone
• Z-2154-2016 · Feb 16, 2016 · Terminated
  7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo
• Z-2158-2016 · Feb 16, 2016 · Terminated
  3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo