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U.S. Department of Health and Human Services

Class 2 Device Recall COMPREHENSIVE REVERSE SHOULDERMINI BASEPLATE

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  Class 2 Device Recall COMPREHENSIVE REVERSE SHOULDERMINI BASEPLATE see related information
Date Initiated by Firm September 02, 2020
Create Date October 09, 2020
Recall Status1 Terminated 3 on December 31, 2020
Recall Number Z-0093-2021
Recall Event ID 86422
510(K)Number K193373  K120121  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis
item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Code Information Lot Numbers:  488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and  564110- UDI (01) 00880304532465 (17) 300609 (10) 564110
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
FDA Determined
Cause 2		 Packaging process control
Action Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier 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 unconsumed 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 must 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.
Quantity in Commerce 3 units
Distribution US Nationwide distribution including in the states of CO, MN, OH, WY.
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 = PHX and Original Applicant = Biomet Inc.
510(K)s with Product Code = PHX and Original Applicant = BIOMET, INC.
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