FDA Device recall Z-0112-2017
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related t…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related t… by Stryker Instruments Div, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0112-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-17 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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
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.
Identifiers
| code_info | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Stryker Instruments Div
- Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part num…
FDA Device · Class II · 2022-07-27 · Stryker Instruments Div - SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090
FDA Device · Class II · 2022-07-27 · Stryker Instruments Div - Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA Device · Class III · 2022-07-27 · Stryker Instruments Div - Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diame…
FDA Device · Class II · 2020-11-18 · Stryker Instruments Div - Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Penci…
FDA Device · Class II · 2020-05-06 · Stryker Instruments Div
All Stryker Instruments Div recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.