Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns
Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to 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 infection and complications from a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 127 units of the Sirus Drill 13mm diameter trauma instrument (Model Number: 02.00020.040). These instruments are used for the preparation of bone in Trauma, Hip, and Shoulder surgeries.
The recall was initiated because the Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions. This deficiency potentially results in infection and subsequent complications for patients.
The affected units were distributed in 31 states and the District of Columbia. Healthcare facilities and users of these instruments should stop using the recalled products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 127
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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