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REFLECTION 71332545Recalls & reported problems

Smith & Nephew, Inc. · REFLECTION SPHERICAL HEAD SCREW 45MM · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010462695), received between Jun 18, 2020 and Jun 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (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

Device problems

  • Material Deformation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 18, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT, DURING SURGERY, DOCTOR DRILLED A HOLE THRU THE R3 3-HOLE CUP AND WHEN TRYING TO INSTALL THE 6.5 X 45 SPHERIC HEAD SCREW IT GOT STUCK AND BEGAN STRIPPING. HE RE-DRILLED INTO THE HOLE AND TRIED TO INSTALL THE SCREW BUT THE SAME THING HAPPENED WITH THE SAME SCREW. PROCEDURE CONCLUDED WITH A BACK-UP DEVICE FROM SMITH AND NEPHEW. A DELAY OF LESS THAN 30 MINUTES AND NO INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10171478 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page