NA 408.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982208873), received between Jan 7, 2025 and Jan 7, 2025 — 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 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZHAO J., CHEN CS, XU ZH, CHEN HF, ZHANG F, WANG QP, ZHOU JL, QUE YD, COMPARISON OF FEMORAL NECK INTERNAL FIXATION SYSTEM AND SIMPLE CONNULATED SCREW INTERNAL FIXATION IN THE TREATMENT OF FEMORAL NECK FRACTURES IN PATIENTS UNDER 65 YEARS OLD, ZHONGGUO ZUZHI GONGCHENG YANJIU. 2023; 27(36):5823-5827. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY WAS A RETROSPECTIVE CASE ANALYSIS AIMING TO OBSERVE THE EFFECT OF A NEW TYPE OF FEMORAL NECK INTERNAL FIXATION SYSTEM IN THE TREATMENT OF FEMORAL NECK FRACTURES. BETWEEN JANUARY 2019 TO JUNE 2020, A TOTAL OF 53 PATIENTS (24 MALE AND 29 FEMALE) WITH A MEAN AGE OF 45.75 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD FEMORAL NECK FRACTURES AND UNDERWENT SURGERY WHERE 21 OF THEM WERE FIXED WITH FEMORAL NECK SYSTEM (DEPUY SYNTHES) OR REFERRED AS THE OBSERVATION GROUP; AND 32 PATIENTS WERE FIXED WITH CANNULATED SCREWS (DEPUY SYNTHES) OR THE CONTROL GROUP. ALL PATIENTS WERE FOLLOWED UP FOR 12-24 MONTHS AFTER SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UN

  Patient problems: Necrosis; Nonunion/Delayed-union Bone Fracture; Physical Asymmetry; Post Operative Wound Infection

  MAUDE report 21094459 ↗

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-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
• 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-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