Zimmer Biomet Flexible Shaft Instruments Recalled for Infection Risk
Zimmer Biomet is recalling 457 Flexible Shaft instruments because they may not clean adequately, posing a risk of infection.
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 risk-of-harm product (infection) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 457 units of the Flexible Shaft hip and anatomical shoulder instrument, Model Number 75.80.04. These instruments are used for bone preparation in Trauma, Hip, and Shoulder surgeries.
The recall was issued because the instruments may not be adequately cleaned when utilizing standard cleaning instructions. This potential cleaning failure could result in infection and subsequent complications for patients.
The affected products were distributed in 31 states and the District of Columbia. Healthcare facilities and users should stop using these instruments and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 457
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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, 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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