NA 02.118.514Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982039200), received between May 22, 2023 and Sep 5, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22984800 ↗
• MalfunctionNov 15, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/14MM. THIS IS REPORT 7 OF 7 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138822 ↗
• MalfunctionNov 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/14MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132631 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/14MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132590 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/14MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132477 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  PACKAGE HAD A HOLE IN ONE SIDE, LOOKED LIKE IT WAS NEVER SEALED AT PACKAGING FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131225 ↗
• MalfunctionMay 22, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, A SCREW WAS RECEIVED FROM THE WAREHOUSE BUT THE BAG WAS EMPTY. THE CONSULTANT DID NOT SEE THAT THE BAG WAS OPEN OR HAD BEEN TAMPERED WITH, IT WAS UNOPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/14MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes