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 Biomet Comprehensive Reverse Shoulder System

  • 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 Biomet Comprehensive Reverse Shoulder System see related information
Date Initiated by Firm February 25, 2020
Create Date March 31, 2020
Recall Status1 Terminated 3 on August 05, 2020
Recall Number Z-1615-2020
Recall Event ID 85143
510(K)Number K120121  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency
Item Number: 010000589
Code Information Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
FDA Determined
Cause 2		 Packaging process control
Action Zimmer Biomet issued notification letter on 2/25/20 via email to the International consignees states reason for recall, health risk and action to take: Hospital Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1  Certification of Acknowledgement Form and send to fieldaction.emea@zimmerbiomet.com.This form must be returned even if you do not have affected products available to return in your facility. 5. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative.
Quantity in Commerce 21 units
Distribution International distribution - country of Netherland.s
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 = PHX and Original Applicant = BIOMET, INC.
-
-