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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 14, 2020
Create Date June 09, 2020
Recall Status1 Terminated 3 on April 08, 2021
Recall Number Z-2305-2020
Recall Event ID 85701
510(K)Number K143697  
Product Classification Plate, fixation, bone - Product Code HRS
Product A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Code Information Lot Number:  P0217 (01)00887868135026(10)P0217 
Recalling Firm/
Manufacturer		 Biomet
6303 Blue Lagoon Dr Ste 100
Miami FL 33126-6023
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Distributed to the field without having completed design history files or design transfer activities
FDA Determined
Cause 2		 Device Design
Action Zimmmer Biomet issued Urgent Medical Device Recall letter , dated May 14, 2020 to Risk Manger, Distributors,Surgeons, stating reason for recall, health risk and action to take: 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. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Quantity in Commerce 5 OUS
Distribution Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
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 = HRS and Original Applicant = Biomet Manufacturing
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