Zimmer Biomet Recalls Reverse Shoulder Humeral Trays Due to Fracture Risk
Zimmer Biomet is recalling 4,388 Comprehensive Reverse Shoulder System Humeral Trays because they are fracturing at higher-than-anticipated rates, posing a risk of revision surgery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that leads to a higher-than-anticipated rate of fracturing and a risk of revision surgery, which aligns with the rubric criteria for 'Severe' (structural defect or significant injury reports).
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,388 units of the Comprehensive Reverse Shoulder System Humeral Tray, Model 115340. The recall is being conducted because the devices are experiencing a higher-than-anticipated rate of fracturing due to a design issue.
The affected devices are distributed nationwide in the United States, as well as in Canada, Australia, Chile, Colombia, Korea, and the Netherlands. The recall covers specific lot numbers, which are listed in the official FDA recall record Z-1103-2017.
The primary hazard associated with this recall is the risk of revision surgery resulting from the fracturing of the humeral tray. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to manage the affected devices.
The recalled product
- Product
- Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4,388
Distribution
Distributed nationwide across the United States.
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