Sidus Stem-Free Shoulder recallZ-2762-2019 · Zimmer GmbH · initiated Aug 21, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Labeling mix-ups
What the company is doing
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 [email protected]. 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 [email protected]
Recall details
- Recall number
- Z-2762-2019
- Status
- Terminated
- Initiated by the company
- Aug 21, 2019
- Recalling firm
- Zimmer GmbH
- Quantity
- 19 unit worldwide
- Product code
- PKC
- FDA submissions
- K171858
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sidus® Stem-Free Shoulder 01.04555.500Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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