NA 47-4840-035-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024101975), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 injury.

15 other recalls cover devices cleared under the same FDA submission (K112885, K143066); 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.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE SYMPTOMS SUBSEQUENTLY RESOLVED AND THE DEVICE REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Complex regional pain syndrome

  MAUDE report 24326964 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112885, K143066. One submission often covers many models, so check the product and lot details in each record.

• Z-1677-2016 · May 4, 2016 · Terminated
  Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellou
• Z-1108-2016 · Jan 11, 2016 · Terminated
  Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixat
• Z-1116-2016 · Jan 11, 2016 · Terminated
  Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC S
• Z-1111-2016 · Jan 11, 2016 · Terminated
  Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixat
• Z-1102-2016 · Jan 11, 2016 · Terminated
  Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X
• Z-2244-2014 · Jul 22, 2014 · Terminated
  Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
• Z-2251-2014 · Jul 22, 2014 · Terminated
  4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
• Z-2245-2014 · Jul 22, 2014 · Terminated
  Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
• Z-2248-2014 · Jul 22, 2014 · Terminated
  6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
• Z-2250-2014 · Jul 22, 2014 · Terminated
  4.5 mm Malleolar Screw Sterile zimmer
• Z-2247-2014 · Jul 22, 2014 · Terminated
  6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
• Z-2246-2014 · Jul 22, 2014 · Terminated
  6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
• Z-2249-2014 · Jul 22, 2014 · Terminated
  6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
• Z-1040-2014 · Oct 11, 2013 · Terminated
  PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM
• Z-1042-2014 · Oct 11, 2013 · Terminated
  1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUC