• 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 Back To Search Results
Device prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
Regulation Description Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Product CodeKWR
Regulation Number 888.3640
Device Class 3

Device Problems
No Information 18
Failure to Adhere or Bond 3
Implant, removal of 3
Explanted 2
No code available 2
Dislodged or dislocated 2
Fracture 1
Loose or intermittent connection 1
Loose 1
Other (for use when an appropriate device code cannot be identified) 1
Malposition of device 1
Dislocated 1
Total Device Problems 36

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II Jun-25-2014

-
-