CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report

Sirus Drill diameter trauma instrument used recalled by Zimmer Biomet

Zimmer Biomet is recalling Sirus Drill diameter trauma instrument used for preparation of bone in Trauma, Hip and, distributed in 32 states. The recall was initiated on 3 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled127

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0919-2018
FDA event ID: 79206
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 3 Oct 2017
FDA classified: 6 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

3 Oct 2017	Recall initiated by company
6 Mar 2018	Classified by FDA	+154 days
14 Mar 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040

Where it was distributed

Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Minnesota Missouri North Carolina

Questions about this recall

Why was it recalled?

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Which lots are affected?

All lots

Where was it sold?

Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79206

Reported	Class	Recall	Company	Reason	Where
14 Mar 2018	CLASS II	Flexible Shaft hip and anatomical shoulder instrument used recalled	Zimmer Biomet	Device Malfunction	32 states

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