Dome Centric component — Class II medical device recall Z-2003-2016
Terminated recall by Zimmer Gmbh, reported 2016-06-22, distributed nationwide. In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humer
| Recall number | Z-2003-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Gmbh, Winterthur, Switzerland |
| Recall initiated | 2016-05-17 |
| Classified | 2016-06-16 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-10-31 |
| Distributed | Nationwide (US) |
| Quantity | 177 |
| Lot numbers | 2792457, 2794576, 2794577, 2794578, 2794579, 2794580, 2812029, 2815118, 2815119, 2817212, 2817213, 2832862, 2844463, 2847568 |
| Model numbers | 01.04227.005 |
Product
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Reason for recall
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.