Zimmer Biomet Recalls Segmental System Proximal Femoral Components
Zimmer Biomet is recalling specific proximal femoral components due to potential machining debris that may not have been adequately removed during cleaning.
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 is classified as FDA Class II, and the hazard involves potential debris in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38. The recall involves 1,145 distribution events of this medical device, which is used to address patients with severe bone loss associated with disease, trauma, or revision.
The recall was initiated because there is a potential for debris in the hole on the superior lateral aspect of the device resulting from machining. This debris may not have been adequately removed during the subsequent cleaning process.
The affected devices were distributed nationwide in the United States and internationally to Australia, South Korea, Malaysia, the Netherlands, and Singapore. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,145
Distribution
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