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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Shoulder System

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  Class 2 Device Recall Comprehensive Shoulder System see related information
Date Initiated by Firm December 08, 2017
Create Date March 13, 2018
Recall Status1 Terminated 3 on September 04, 2018
Recall Number Z-0979-2018
Recall Event ID 79385
510(K)Number K060692  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product Humeral Stem 83mm(Size 17)

Product Usage:
Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Code Information PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		 Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.
Quantity in Commerce 12
Distribution US Nationwide in the states of MN, NJ, CA, TX, ND
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 = HSD and Original Applicant = BIOMET MANUFACTURING CORP.
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