Recall record at a glance
| Official record | Z-0112-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Report date | Oct 26, 2016 |
| Recall initiation date | Aug 17, 2016 |
| Quantity | 225 |
| Location | Portage, MI, United States |
Official 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)
Why the product was recalled
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 information
US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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