Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.
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 risk-of-harm medical device where the hazard is a mechanical failure (tab fracture) that could lead to injury, but the source text does not explicitly report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling the REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, specifically the Glenosphere Helmet, 40 mm Diameter Nonsterile. The product is instrumentation used in shoulder replacement surgery, where the glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact.
The recall is being conducted because there is a potential for one or both tabs of the Trabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. The source text notes that there have been 47 reported complaints of tab fracture.
The affected units were distributed worldwide, including nationwide in the USA and internationally to numerous countries. The total quantity involved is 3,163 units across both sizes. Healthcare providers and facilities should stop using the affected instrumentation and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
- Manufacturer
- Zimmer, Inc.
- Affected units
- 3,163
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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