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U.S. Department of Health and Human Services

Class 2 Device Recall Dual Mobility VivacitE

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  Class 2 Device Recall Dual Mobility VivacitE see related information
Date Initiated by Firm August 14, 2020
Create Date October 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-0057-2021
Recall Event ID 86404
510(K)Number K190656  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Dual Mobility Vivacit-E Bearing, Model Number 110031009
Code Information Lot Number 64755636
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
FDA Determined
Cause 2
Under Investigation by firm
Action Urgent Medical Device Recall notification letters dated 8/14/20 were sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. If the product has been implanted, Zimmer Biomet recommends assessing the patient with imaging and monitoring the patient for the potential health risks. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred
Quantity in Commerce 31
Distribution Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = Zimmer Inc.
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