NA 208.415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982149220), received between Mar 2, 2021 and Sep 6, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 PATIENT HAD A FRACTURE AND HAD UNDERGONE PINNING PERCUTANEOUS HIP. ON (B)(6) 2018 OPERATIVE REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC HIP PAIN RIGHT, HAD REMOVAL OF SCREWS ALSO AND HAD UNDERGONE A TOTAL HIP ARTHROPLASTY LEFT (ZIMMER/BIOMET DEVICE WITH OMNI LIFE FEMORAL STEM). 6.5MM CANNULATED SCREW 16MM THREAD 80MM (PART #208.411 , LOT # UNKNOWN, QUANTITY# 1). 6.5MM CANNULATED SCREW 16MM THREAD 90MM (PART # 208.413 , LOT # UNKNOWN, QUANTITY# 1). 6.5MM CANNULATED SCREW 16MM THREAD 105MM (PART #208.416, LOT # UNKNOWN, QUANTITY# 1). 6.5MM CANNULATED SCREW 16MM THREAD 100MM (PART #208.415, LOT # UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (16.5MM 6.5MM CANNULATED SCREW 16MM THREAD 100MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15364739 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT HAD THREE (3) 6.5MM CANNULATED SCREWS PLACE IN THE FEMORAL NECK FOR FIXATION DUE TO A FRACTURE. THE ORIGINAL SURGERY WAS PERFORMED IN A DIFFERENT STATE SO DETAILS OF THE ORIGINAL INCIDENT ARE MINIMAL. THE PATIENT HEALED COMPLETELY BUT IS VERY THIN AND HAD PAIN CAUSED BY THE HEADS OF THE SCREWS WHEN LAYING ON HIS SIDE. DUE TO THE COMPLETE HEALING, THE SURGEON FELT IT APPROPRIATE TO REMOVE THE NO LONGER NEEDED SCREWS TO IMPROVE PATIENT COMFORT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 6.5MM CANNULATED SCREW 16MM THREAD 100MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11398407 ↗

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-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-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-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-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-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