NA 408.414Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982208965), received between Sep 8, 2022 and Sep 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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 18, 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.

• InjurySep 8, 2022Device Slipped; No Apparent Adverse Event; Device Slipped; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PINNING OF THE RIGHT HIP ON (B)(6) 2021. THE PATIENT SUFFERED SEVERE PAIN AND LACK OF MOBILITY; HER HIP WAS UNABLE TO HEAL PROPERLY, AND SHE HAS PERMANENT DAMAGE IN HER HIP WHICH HAS CAUSED EMOTIONAL DISTRESS. ON OR ABOUT (B)(6) 2021, THE PATIENT UNDERWENT SURGERY TO REMOVE THE SCREWS WHICH HAD BECOME LOOSE AND HINDERED HEALING OF THE HIP. THIS REPORT INVOLVES ONE UNK - SCREWS: CANNULATED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Distress; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15380631 ↗

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-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-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-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-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-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