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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Small Diameter Cement Plug Inserter

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  Class 2 Device Recall Biomet Small Diameter Cement Plug Inserter see related information
Date Initiated by Firm February 28, 2019
Create Date April 01, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-1081-2019
Recall Event ID 82324
510(K)Number K033280  
Product Classification Dispenser, cement - Product Code KIH
Product Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices
Item Number: 414989
Code Information All lots
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Lack of an adequate sterilization validation
FDA Determined
Cause 2		 Process design
Action Zimmer Biomet issued recall letter on 2/28/19 via FedEx and email identifying reason for recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Surgeons provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions - Returning Certificate of Acknowledgment to Zimmer Biomet. " Hospital risk managers provided with a letter identifying the issue and their responsibilities. 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
Quantity in Commerce 89 units
Distribution Nationwide
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 = KIH and Original Applicant = BIOMET, INC.
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