510(k) K113550 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
VANGUARD COMPLETE KNEE SYSTEM
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 29, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses.
Item Number: 183104
(2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm
Item Numb Open, Classified |
JWH | None listed |
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122
EXPANDED RECALL:
(2) Vanguard Knee System PS Open Box Femoral; Left; Open, Classified |
JWH | None listed |
| Oct 22, 2018 | Zimmer Biomet, Inc. Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm
Item Number: 183126 Terminated |
JWH | None listed |
| Oct 22, 2018 | Zimmer Biomet, Inc. Vanguard Knee System -PS Open Box Femoral Right, 65 mm
Item Number:183108 Terminated |
JWH | None listed |
| Jun 4, 2018 | Zimmer Biomet, Inc. Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642
Product Usage: The product is intended for use in knee joint replacement arthroplasties. Terminated |
JWH | None listed |
| Jun 1, 2018 | Zimmer Biomet, Inc. Vanguard Knee System PS Tibial Bearing, Part Number 183621
Intended for use in knee joint replacement procedures. Terminated |
JWH | None listed |
| Oct 3, 2017 | Zimmer Biomet, Inc. Vanguard CR Porous Femoral 62.5mm (Left Femur)
For use in total knee arthroplasty Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.