NA 208.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982149183), received between Apr 21, 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). NO FURTHER INFORMATION IS AVAILABLE. 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 (1) 6.5MM CANNULATED SCREW 16MM THREAD 80MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15364768 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF THREE (3) CANNULATED SCREWS AND ONE (1) WASHER AND WAS REVISED TO HEMIARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 6.5MM CANNULATED SCREW 16MM THREAD 80MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11704135 ↗

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-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-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-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-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-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