510(k) K063569 ยท PHX Shoulder Prosthesis, Reverse Configuration
EQUINOXE REVERSE SHOULDER SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Nov 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2025 | Exactech, Inc. Exactech Equinoxe, Reverse Shoulder Humeral Liners,
REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/
320-38-03,145-DEG PE 38MM HUM LINER +2.5/
320-42-00,145-DEG PE 42MM HUM LINER +0/
320-42-03,145-DEG PE Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner:
a) +0mm, Item Number 320-38-00,
b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner:
a) +0mm, Item Number 320-38-10,
b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Jan 18, 2024 | Exactech, Inc. Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:
a) 320-36-00,
b) 320-36-03,
c) 320-36-04,
d) 320-36-10,
e) 320-36-13,
f) 320-38-00,
g) 320-38-13,
h) 320-40-00,
i) 320-40-10,
j) Open, Classified |
KWT | None listed |
| Aug 24, 2020 | Exactech, Inc. Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. Terminated |
PHX | None listed |
| Aug 24, 2020 | Exactech, Inc. Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. Terminated |
PHX | None listed |
| Aug 21, 2018 | Exactech, Inc. Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00
Product Usage:
Shoulder surgery Open, Classified |
KWT | None listed |
| Oct 25, 2016 | Exactech, Inc. Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit Terminated |
KWT | None listed |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Compression Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.