Depuy (Ireland)

Country not established FDA

Devices: 5,986
Registrations: FDA
FDA recalls: 1111 ongoing

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5,986

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Company details

DUNS number: 989365556
Email: [email protected]
Phone: +1(800)255-2500

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 11 recalls initiated by DEPUY (IRELAND), the earliest on 2026-04-03 and the most recent on 2026-05-19. By recorded status: 11 ongoing. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 11

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. Distribution: Distribution to MN, NC, TX. Submission number: K242871
- 19 May 2026 Z-2617-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: Distribution to MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1985-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1986-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1987-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1988-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1989-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1990-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1991-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871
- 3 Apr 2026 Z-1992-2026 Class II Ongoing The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871

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. Distribution: US Nationwide distribution in the states of MN, NC, TX. Submission number: K242871

FDA establishments1

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

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

Frequently asked questions

How many devices does DEPUY (IRELAND) have in the registry?

The registry currently lists 5986 devices for DEPUY (IRELAND). Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for DEPUY (IRELAND)?

FDA recall records list 11 recalls initiated by DEPUY (IRELAND), the most recent initiated on 19 May 2026. 11 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

Which FDA establishments are linked to DEPUY (IRELAND)?

1 FDA establishment is linked to DEPUY (IRELAND) in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.