Scorpio 72-4-7518Recalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer Tibial Insert · Class 2 · Implant

All models of Scorpio (107)

Data updated Oct 16, 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: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

9 other recalls cover devices cleared under the same FDA submission (K243817, K994128); 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.

Recalls naming this device

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-0880-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243817, K994128. One submission often covers many models, so check the product and lot details in each record.

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-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-0882-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Z-0877-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Z-0875-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Z-0881-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Z-0876-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Z-0879-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Z-0878-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Device details

UDI-DI	`07613327034813`
Brand	Scorpio
Model	72-4-7518
Company	Howmedica Osteonics Corp.
Product code	JWH · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Class	Class 2
FDA submission	K243817, K994128
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 4, 2025

Device type (GMDN): Tibial insert

An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

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

ATTUNE 1506-00-005
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
589 reports
ATTUNE 1506-00-004
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
580 reports
JOURNEY 74012812
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
502 reports
JOURNEY 74011856
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
438 reports
PERSONA™ 42-5099-094-00
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
406 reports
JOURNEY 74011857
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
388 reports
ATTUNE 1506-00-007
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
288 reports
ATTUNE 1506-00-003
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
271 reports

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

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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