Recall Z-0112-2017 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
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
| Date | Oct 18, 2016 (initiated Aug 17, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Packaging |
| Action | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM, product number 6118-097-090, lot number 16029017, due to a breach in the packaging causing a breach in sterility. There is a potential for a bone or soft tissue infection which may require medical or surgical intervention. Customer notices were issued via certified mail on 08/17/2016. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many Sagittal Blades from the affected lot (listed above) are at you |
| Quantity | 225 |
| Distribution | US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.