Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns
Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling reusable instruments used in the Knee, Hip, Trauma, and Extremities segments. The recall was initiated because the durability characteristics of these instruments were not established.
The recall covers all lots in distribution prior to May 8, 2017. The company distributed these instruments nationwide and worldwide, with more than 10,000,000 units distributed over the last 10 years.
Consumers and healthcare facilities should stop using the affected instruments and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots in distribution prior to 5/8/17
Distribution
Distributed nationwide across the United States.
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