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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 April 26, 2017
Create Date June 01, 2017
Recall Status1 Terminated 3 on March 30, 2018
Recall Number Z-2216-2017
Recall Event ID 77119
510(K)Number K060694  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot.
This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty
Code Information Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956, Lot Number: 270260, UDI Number: (01) 00880304462618 (17) 211204 (10) 270260
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
800-348-2759
Manufacturer Reason
for Recall		 Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.
FDA Determined
Cause 2		 Under Investigation by firm
Action Zimmer Biomet initiated a voluntary recall on April 26, 2017, for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-conforming threads. Notices were distributed via FedEx to customers. Risk Managers were instructed as follows: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy within three (3) to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574- 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Surgeons were instructed as follows: Review the notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow up schedule. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a co
Quantity in Commerce 16
Distribution Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada
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 MANUFACTURING CORP.
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