Exact FDA event identifier

Event 79206

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 03, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

Z-0918-2018

Recall number: Z-0918-2018
Initiated: October 03, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 457

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots

Distribution pattern

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.

device · product 2 of 2

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

Z-0919-2018

Recall number: Z-0919-2018
Initiated: October 03, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 127

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots

Distribution pattern

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.