Data / Medical devices / Ireland / Zimmer Orthopedics Manufacturing Limited-Galway
Zimmer Orthopedics Manufacturing Limited-Galway: FDA-registered device maker in Oranmore Galway(County), Ireland, 11 510(k) clearances
Zimmer Orthopedics Manufacturing Limited-Galway is registered with the FDA (registration 3012319330) in Oranmore Galway(County), Ireland. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 29, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012319330
- Address
- Deerpark Industrial Estate, Oranmore Galway(County), Ireland, Galway
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 4, 2012
- Registered through
- 2027
- Brand names listed
- COMPREHENSIVE PRIMARY SHOULDER STEMS, Comprehensive Shoulder System, G7 ACETABULAR SYSTEM-LTF Zimmer Design Control, G7 OSSEOTI ACETUBLAR SHELLS, Persona Knee System-CPS, Persona Natural Tibia Baseplates Size J and Instrumentation, Persona OsseoTi 3-Peg Patella, Persona Partial Knee and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2024 | K243247 | Persona the Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 26, 2024 | K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 8, 2023 | K230321 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 17, 2022 | K221479 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 17, 2018 | K172524 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 20, 2015 | K150090 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 22, 2013 | K130143 | PERSONA NATURAL TIBIA BASEPLATES | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 22, 2013 | K123459 | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 9, 2012 | K122765 | PERSONA NATURAL TIBIA BASEPLATES | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 7, 2012 | K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 27, 2012 | K113369 | ZIMMER PERSONA KNEE SYSTEM | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 3, 2025 | 96398 | Class II | Ongoing | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Updated March 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.