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U.S. Department of Health and Human Services

Class 2 Device Recall Sidus StemFree Shoulder

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 Class 2 Device Recall Sidus StemFree Shouldersee related information
Date Initiated by FirmAugust 21, 2019
Create DateSeptember 27, 2019
Recall Status1 Terminated 3 on July 20, 2020
Recall NumberZ-2762-2019
Recall Event ID 83689
510(K)NumberK171858 
Product Classification Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-co - Product Code PKC
ProductSidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
Code Information Lot # 2941696  UDI: (01) 00889024415973 (17) 280299 (10) 2941696
Recalling Firm/
Manufacturer		 Zimmer GmbH
Sulzerallee 8
Winterthur Switzerland
For Additional Information Contact411 Technical Services
574-3713071
Manufacturer Reason
for Recall		Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
FDA Determined
Cause 2		Labeling mix-ups
ActionFirm sent letter 8/21/2019 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, quarantine the product and notify the sales representative 3. Complete 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. 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 Commerce19 unit worldwide
DistributionWorldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PKC
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