510(k) K170748 ยท PHX Shoulder Prosthesis, Reverse Configuration
GLOBAL UNITE Platform Shoulder System
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, Jan 11, 2018 |
| Received | Mar 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 6
Part Number: 11000610 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 8
Part Number: 110008100 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 8
Part Number: 110008600 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 10
Part Number: 110010100 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 10
Product Code: 110010600 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 12
Product Code: 110012100 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 14
Product Code: 110014100 Terminated |
PHX | None listed |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 16
Product Code: 110016100 Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.