510(k) K080642 ยท PHX Shoulder Prosthesis, Reverse Configuration
COMPREHENSIVE REVERSE SHOULDER
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 9, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Extremities
Item Number:
1)113954 Hybrid Glenoid Glenoid Base, 4 MM
2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard
3) XL-115364 Comprehensive Reverse Sh Terminated |
PHX | None listed |
| Mar 13, 2020 | Biomet, Inc. Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral sid Terminated |
PHX | None listed |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Extremities, Shoulders and Elbows
BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System
Product Usage:
Shoulder Replacement E Terminated |
KWS | None listed |
| Feb 11, 2017 | Zimmer Biomet, Inc. Comprehensive Reverse Shoulder System Humeral Tray
Model 115340 Terminated |
PAO | None listed |
| Jun 17, 2013 | Biomet, Inc. Superior Approach Resection Guide Assembly.
Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. Terminated |
PAO | None listed |
| Jun 9, 2011 | Biomet, Inc. Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indica Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indi Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indic Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are i Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients wh Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint ha Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indica Terminated |
KWS | None listed |
| Jun 9, 2011 | Biomet, Inc. Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for Terminated |
KWS | None listed |
| Dec 16, 2010 | Biomet, Inc. Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, REF 115350, Biomet Orthopedics, Warsaw, IN
Intended for total shoulder replacement in a reverse configurati Terminated |
KWS | None listed |
| Dec 16, 2010 | Biomet, Inc. Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN
Intended for total shoulder replacement in a reverse configurat Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.