The Recall Desk
HighFDA (Devices)·Z-0172-2015·Announced 2014-11-12

Stryker SmartLife Aseptic Housings Recalled for Welding Defect

Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device where a component may separate, creating a risk of harm, but the source text does not report any injuries or illnesses.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 3,138 units of the SmartLife Large Aseptic Housing (REF 7126-120-000). The recall is due to a defect where the top section of the housing may separate from the bottom section caused by insufficient welding.

The affected products are designed to be used with SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. The recall covers part number 7126-120-000 and all lot numbers from 13027 to 14093.

Distribution was worldwide, including the United States and countries such as Australia, Canada, Sweden, the Netherlands, France, Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.

The recalled product

Product
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 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 Hand
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Handpiece Accessories
Hazard
Affected units
3,138

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number 7126-120-000
  • All lot numbers from 13027 to 14093

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · structural failure

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