NA 47-2348-012-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024087668), received between Oct 10, 2019 and Oct 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K111447); 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.

• InjuryOct 14, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO APPARENT INFECTION. IT WAS FURTHER REPORTED THAT A SCREW BACKED OUT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 9185153 ↗
• InjuryOct 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO APPARENT INFECTION. IT WAS FURTHER REPORTED THAT A SCREW BACKED OUT.

  Patient problems: Unspecified Infection

  MAUDE report 9175775 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111447. One submission often covers many models, so check the product and lot details in each record.

• Z-1676-2016 · May 4, 2016 · Terminated
  Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
• Z-1154-2016 · Jan 11, 2016 · Terminated
  Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SC
• Z-1105-2016 · Jan 11, 2016 · Terminated
  Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR
• Z-2549-2014 · Jul 22, 2014 · Terminated
  Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X1