CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
Sagittal Blade .97X90MM recalled by Stryker Instruments Div. of
Stryker Instruments Div. of Stryker is recalling Sagittal Blade .97X90MM, distributed nationwide in the US. The recall was initiated on 17 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0112-2017
- FDA event ID
- 75018
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2016
- FDA classified
- 17 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 17 Aug 2016 | Recall initiated by company | |
| 17 Oct 2016 | Classified by FDA | +61 days |
| 26 Oct 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
Nationwide CaliforniaColoradoFloridaIdahoMarylandNorth DakotaRhode IslandTexasWashingtonWisconsin
Questions about this recall
Is Sagittal Blade .97X90MM recalled?
Yes. Stryker Instruments Div. of Stryker recalled Sagittal Blade .97X90MM on 17 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-0112-2017.
Why was it 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.
Which lots are affected?
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017
Where was it sold?
US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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