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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Comprehensive Reverse Shoulder

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  Class 2 Device Recall Biomet Comprehensive Reverse Shoulder see related information
Date Initiated by Firm December 21, 2018
Create Date March 01, 2019
Recall Status1 Terminated 3 on May 06, 2020
Recall Number Z-0972-2019
Recall Event ID 81118
510(K)Number K120121  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Code Information Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall		 The product was potentially being packaged without a taper adapter.
FDA Determined
Cause 2		 Packaging process control
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letters dated 12/21/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 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 52
Distribution US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
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, INC.
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