Sagittal Blade 18 — Class II medical device recall Z-0112-2017
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-10-26, distributed nationwide. Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a steri
| Recall number | Z-0112-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2016-08-17 |
| Classified | 2016-10-17 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR, IT, NL, NZ |
| Quantity | 225 |
| Reason classes | sterility |
| Lot numbers | 16029017 |
| Model numbers | 6118-097-090 |
Product
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)
Reason for recall
Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.
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-0112-2017. 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.