510(k) K120121 ยท PHX Shoulder Prosthesis, Reverse Configuration
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Jan 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2020 | Biomet, Inc. Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis
item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder p Terminated |
PHX | None listed |
| Feb 25, 2020 | Biomet, Inc. Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disab Terminated |
PHX | None listed |
| Dec 21, 2018 | Zimmer Biomet, Inc. Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose sho Terminated |
KWS | None listed |
| Feb 24, 2015 | Biomet, Inc. Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor,
Part Number: 010000589
Lot: 527400 Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.