Recall Z-2762-2019 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Zimmer GmbH
Sidus 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.
| Date | Aug 21, 2019 |
| Status | Terminated |
| Reason | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. |
| Root cause | Labeling mix-ups |
| Action | Firm 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 |
| Quantity | 19 unit worldwide |
| Distribution | Worldwide 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171858 | Sidus Stem-Free Shoulder Zimmer GmbH, Dec 18, 2017 |