NA 47-4828-016-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024100671), received between Mar 19, 2022 and Mar 19, 2022 — classified as 4 injuries.

4 other recalls cover devices cleared under the same FDA submission (K063303); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. SUBSEQUENTLY SWELLING, PAIN, SENSITIVITY, DISCOLORATION, AND UNABLE TO WEAR SHOES WAS REPORTED WITH PLATE AND ALL SCREWS REMOVED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 13826396 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. SUBSEQUENTLY SWELLING, PAIN, SENSITIVITY, DISCOLORATION, AND UNABLE TO WEAR SHOES WAS REPORTED WITH PLATE AND ALL SCREWS REMOVED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 13826294 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. SUBSEQUENTLY SWELLING, PAIN, SENSITIVITY, DISCOLORATION, AND UNABLE TO WEARSHOES WAS REPORTED WITH PLATE AND ALL SCREWS REMOVED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 13826288 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. SUBSEQUENTLY SWELLING, PAIN, SENSITIVITY, DISCOLORATION, AND UNABLE TO WEAR SHOES WAS REPORTED WITH PLATE AND ALL SCREWS REMOVED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 13826249 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063303. One submission often covers many models, so check the product and lot details in each record.

• Z-0312-2020 · Oct 10, 2019 · Terminated
  Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 4749
• Z-1674-2016 · May 4, 2016 · Terminated
  Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
• Z-1103-2016 · Jan 11, 2016 · Terminated
  Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7M
• 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