Z-0918-2018Class II

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and...

Name: Z-0918-2018 Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and...
Creator: Zimmer Biomet, Inc.
Published: 2017-10-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-03 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04 on 2017-10-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0918-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Posted: 2018-03-06
Terminated: 2018-08-20
Recalling firm: Zimmer GmbH
Product: Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Review the notification and ensure affected personnel are aware of contents. Assist Zimmer Biomet sales representative in locating and quarantining affected product. Sales representative will remove product from facility. Complete certificate of acknowledgement and return to Zimmer Biomet. Distributors are asked to locate and quarantine all affected product in inventory and from affected hospitals in their territory.
Quantity in commerce: 457
Distribution: 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0919-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)