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

Class 2 Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor

  • 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
  Class 2 Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor see related information
Date Initiated by Firm January 07, 2015
Date Posted February 24, 2015
Recall Status1 Terminated 3 on October 22, 2015
Recall Number Z-1208-2015
Recall Event ID 70297
510(K)Number K120121  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor,
Part Number: 010000589
Lot: 527400
Code Information Part Number: 010000589 Lot: 527400
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639
Manufacturer Reason
for Recall		 The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
FDA Determined
Cause 2		 Process control
Action Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 11- 6 consumed, 5 with distributors
Distribution Domestic: AL, FL, NY, TX Foreign: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = BIOMET, INC.
-
-