NA 208.439Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982149442), received between Apr 28, 2022 and Apr 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryApr 28, 2022Migration; Migration

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY INITIALLY PERFORMED ON (B)(6) 2021, A PATIENT UNDERWENT HARDWARE REMOVAL OF A SCREW DEVICE ON (B)(6) 2022, (B)(6) 2022 DUE TO SCREW PROMINENCE AS IT CAME OFF OF THE PELVIS. ACCORDING TO THE REPORT, THE DEVICE WAS REMOVED WITHOUT COMPLICATION. IT WAS REPORTED THAT THE IMPLANT WAS IN THE WASHER DEVICE THAT WAS LEFT IN THE PATIENT AND NOT RETRIEVED. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE POSTOPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 6.5MM CANNULATED SCREW 32MM THREAD 85MM DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Pain

  MAUDE report 14245626 ↗

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-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-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-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-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-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
• 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-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