Z-0112-2017 Class II Terminated
FDA device recall Z-0112-2017 was initiated by Stryker Instruments Div. Of Stryker Corporation on Aug 17, 2016 and is designated Class II. 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. The recall status is terminated (terminated Mar 29, 2017). Affected quantity: 225.
Recall details
- Product Type
- Devices
- Report Date
- Oct 26, 2016
- Initiation Date
- Aug 17, 2016
- Termination Date
- Mar 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225
Product description
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.
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
Code information
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0112-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026