FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
- Recall number
- Z-0919-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
- Status
- Terminated
- Initiated
- 2017-10-03
- Posted
- not on file
- Terminated
- 2018-08-20
- Reason
- 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
- 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
- 127
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28