REFLECTION 71336258Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010452757), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K090982, K211176, K990666); 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. How this data works · Data updated Oct 13, 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 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR THAT HAD BEEN PERFORMED ON 2003, THERE WAS A REVISION SURGERY TO ADDRESS AN UNSPECIFIED EVENT. THE REF HA THREE HOLE 58MM WAS EXPLANTED. THE CURRENT STATUS OF PATIENT¿S HEALTH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090982, K211176, K990666. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-2297-2016 · Jul 6, 2016 · Terminated
  SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revis