Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 2
LIMA-LTO S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 168 168
2015 176 176
2016 445 445
2017 558 558
2018 481 481
2019 421 421
2020 216 216
2021 228 228
2022 275 275
2023 384 384
2024 176 176

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2018
2 Biomet, Inc. II Dec-05-2012
3 Exactech, Inc. II Jan-18-2024
4 Exactech, Inc. II Oct-03-2018
5 Exactech, Inc. II Dec-22-2016
6 Exactech, Inc. II Jul-31-2012
7 Limacorporate S.p.A II Sep-02-2015
8 Zimmer Biomet, Inc. II Nov-07-2019
9 Zimmer Biomet, Inc. II Dec-29-2017
10 Zimmer Biomet, Inc. II Sep-22-2017
11 Zimmer Inc. II Dec-09-2010
12 Zimmer, Inc. II Feb-26-2014
13 Zimmer, Inc. II Feb-24-2014
14 Zimmer, Inc. II Dec-30-2013
15 Zimmer, Inc. II Aug-26-2013
16 Zimmer, Inc. II Nov-06-2012
17 Zimmer, Inc. II Jun-27-2012
-
-