Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues
Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a functional defect can lead to significant surgical complications, including increased infection risk and the need for additional anesthesia, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer GmbH is recalling 177 units of the Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. This component is used in long-term shoulder joint implants to connect the Humeral Stem to the Humeral Head and set positioning. The affected units were distributed nationwide to Arizona, California, Colorado, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Missouri, Ohio, Pennsylvania, Tennessee, and Texas.
The recall was initiated because, in some cases, it has been difficult or impossible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after the initial positioning of the AS Humeral Trial Head. This issue can result in the entire construct being removed from the humeral canal. Such difficulties may cause delays in surgery time or lead a surgeon to close the wound without finishing the surgery, which increases the risk of infection or the need for a second use of anesthesia.
Healthcare providers should stop using the affected Dome Centric components and contact Zimmer GmbH for instructions on returning the product. Patients who have already received this implant should contact their healthcare provider if they have concerns about their surgery or recovery.
The recalled product
- 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
- Manufacturer
- Zimmer Gmbh
- Affected units
- 177
Distribution
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