Device 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)
Z-0112-2017
Product summary
- Event
- Event 75018
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225
- Official record key
device-enforcement:Z-0112-2017
Official wording
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.
Code information: Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017
Distribution pattern: US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
Derived failure modes
-
Sterility assurance
sterile barrier breach