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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Reverse Shoulder System

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  Class 2 Device Recall Comprehensive Reverse Shoulder System see related information
Date Initiated by Firm January 15, 2021
Create Date February 17, 2021
Recall Status1 Terminated 3 on March 09, 2023
Recall Number Z-1131-2021
Recall Event ID 87201
510(K)Number K132239  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Code Information Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170
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		 Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
FDA Determined
Cause 2		 Labeling Change Control
Action On 01/19/2019, Zimmer Biomet issued Urgent Medical Device Recall notices to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Quantity in Commerce 49
Distribution US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
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 MANUFACTURING CORP.
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