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DJO SURGICAL 410-35-108Recalls & reported problems

Encore Medical, L.P. · NECK, FEMORAL, MODULAR, 35MM 8° CERASIVE TAPER · Class 2 · Implant

Data updated Oct 18, 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 00888912076616), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K000817); 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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Loose or Intermittent Connection1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjurySep 9, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - THE NECK HAD LOOSENED FROM THE STEM. POLY WAS EXCHANGED AS A PRECAUTION.

    Patient problems: Insufficient Information

    MAUDE report 12448917 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000817. One submission often covers many models, so check the product and lot details in each record.

  • Z-1868-2008 · May 8, 2008 · Terminated
    Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orienta
  • Z-1065-2007 · Apr 12, 2007 · Terminated
    ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Sing
  • Z-1064-2007 · Apr 12, 2007 · Terminated
    ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distribut
  • Z-1066-2007 · Apr 12, 2007 · Terminated
    ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Si
  • Z-1063-2007 · Apr 12, 2007 · Terminated
    ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distribut

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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