Sirus Drill 13mm diameter trauma instrument used for preparation of… — Class II medical device recall Z-0919-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-14, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard clean
| Recall number | Z-0919-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-10-03 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-08-20 |
| Distributed | AL, AZ, CA, CO, CT, DC, 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 |
| Quantity | 127 |
| Model numbers | 02.00020.040 |
Product
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0919-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.