CLASS II Device recall · Reported 12 Nov 2014 · FDA Enforcement Report
Stryker SmartLife Small Aseptic Housing recalled
Stryker Instruments Div. of Stryker is recalling Stryker SmartLife Small Aseptic Housing, distributed nationwide in the US. The recall was initiated on 8 Oct 2014 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-0173-2015
- FDA event ID
- 69382
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2014
- FDA classified
- 5 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Oct 2014 | Recall initiated by company | |
| 5 Nov 2014 | Classified by FDA | +28 days |
| 12 Nov 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
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
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
Where it was distributed
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
Nationwide ArizonaCaliforniaDelawareGeorgiaIllinoisKansasKentuckyMarylandMichiganMinnesotaMontanaNew MexicoNew YorkPennsylvaniaTexasWisconsinWyoming
Questions about this recall
Is Stryker SmartLife Small Aseptic Housing recalled?
Yes. Stryker Instruments Div. of Stryker recalled Stryker SmartLife Small Aseptic Housing on 8 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0173-2015.
Why was it recalled?
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Which lots are affected?
Part Number 7222-120-000; All lot numbers from 13072 to 14121
Where was it sold?
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
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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