Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a mechanical defect (tab fracture) that poses a risk of harm during surgery, but the source text does not report any injuries, hospitalizations, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer, Inc. is recalling the REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, specifically the Glenosphere Helmet, 36 mm Diameter Nonsterile. This instrumentation is used in shoulder replacement surgery to insert the glenosphere onto the base plate prior to impaction. The recall involves 3,163 units distributed worldwide, including the United States and various international markets.
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.
Healthcare providers and facilities that have received this product should stop using it and contact Zimmer, Inc. for further instructions on return or replacement. Patients who have already had surgery using this specific instrumentation should consult their healthcare provider if they have concerns.
The recalled product
- Product
- REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 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…
- 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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Similar recalls
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FDA (Devices) · 2013-09-04
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