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Scorpio 72-16-0910Recalls & reported problems

Howmedica Osteonics Corp. · Cruciate Retaining Tibial Insert · Class 2 · Implant

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154020645), received between May 6, 2022 and May 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K011643, K243817); 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.

Recalls naming this device

  1. Dec 1, 2023Open, Classified

    Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

    Z-0885-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn1

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.

  • InjuryMay 6, 2022Naturally Worn; Naturally Worn

    POLY LINER EXCHANGE DUE TO NORMAL WEAR, TOTAL LEFT KNEE.

    Patient problems: Insufficient Information

    MAUDE report 14301825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011643, K243817. One submission often covers many models, so check the product and lot details in each record.

  • Z-3197-2026 · Jul 30, 2026 · Open, Classified
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PAT
  • Z-3206-2026 · Jul 30, 2026 · Open, Classified
    SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyet
  • Z-0884-2024 · Dec 1, 2023 · Open, Classified
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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