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DEPUY (IRELAND)

US Last updated 24 May 2026

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Devices
5,986
Registries
GUDIDEUDAMEDFDA
FDA recalls
1111 ongoing

Catalogue5,986

Page 1 of 40

Showing 1-50 of 5,986

FDA recalls11

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 11 recalls.

  • 2026

    • 19 May 2026 Z-2616-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 19 May 2026 Z-2617-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1985-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1986-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1987-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1988-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1989-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1990-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1991-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
    • 3 Apr 2026 Z-1992-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Show all 11 recalls

  • 2026

    • 3 Apr 2026 Z-1993-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Depuy (Ireland) CO. CORK Munster · IE FEI 3002854251

What DEPUY (IRELAND) makes

The company manufactures orthopaedic knee replacement components, including uncoated and coated polyethylene tibial inserts, metallic femoral prostheses, and trial versions for positioning during surgery. It also produces reusable orthopaedic instruments such as acetabulum prosthesis trials, knee tibia prosthesis trials, and instrumentation trays for surgical procedures. Additional offerings include one-piece femoral stem prostheses and specialized knee prostheses like the P.F.C. SIGMA, RECLAIM, and AUTOBLOQUANTE systems.

The portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does DePuy (Ireland) manufacture?

DePuy (Ireland) specializes in orthopaedic knee replacement components. This includes uncoated and coated polyethylene tibial inserts, metallic femoral prostheses, and trial versions of knee and acetabulum prostheses used during surgery for precise positioning. They also produce reusable orthopaedic instruments like instrumentation trays and trial components for surgical procedures, such as knee tibia and acetabulum prosthesis trials.

Where is DePuy (Ireland) based, and how does this affect its regulatory compliance?

DePuy (Ireland) is based in the United States, where it operates under the jurisdiction of U.S. regulatory requirements for medical devices. Since the company manufactures devices classified under FDA categories Class I, II, and III, it must comply with U.S. regulations, including listing its products in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory transparency.

Which regulatory registries list DePuy (Ireland)’s devices?

DePuy (Ireland)’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and use, ensuring regulatory tracking and compliance with U.S. requirements. This registry helps healthcare providers and regulators verify device details, including classification and manufacturer information.

How are DePuy (Ireland)’s devices classified under FDA regulations?

DePuy (Ireland)’s devices fall into three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class III (high-risk devices requiring premarket approval). The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as knee prostheses or surgical instruments. For example, knee replacement components like the P.F.C. SIGMA or ATTUNE systems are typically Class III due to their critical role in patient care.

What distinguishes DePuy (Ireland)’s reusable orthopaedic instruments from its implantable devices?

DePuy (Ireland)’s reusable orthopaedic instruments, such as instrumentation trays, knee tibia prosthesis trials, and acetabulum prosthesis trials, are designed for surgical planning and positioning rather than permanent implantation. Unlike implantable devices like the P.F.C. SIGMA knee prosthesis or coated femoral stems, these instruments are intended for single-use per patient or repeated use with proper sterilization between procedures. Their classification (Class I or II) reflects lower risk compared to implantables, as they do not remain in the patient’s body long-term.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Website
xx.xx
Phone
+1(800)255-2500
DUNS number
989365556