The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0173-2015·Announced 2014-11-12

Stryker SmartLife Aseptic Housings Recalled for Welding Defect

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II. The hazard involves a structural defect (separation of housing sections) in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 3,138 units of the SmartLife Small Aseptic Housing (REF 7222-120-000). The recall is due to a manufacturing defect where the top section of the housing may separate from the bottom section because of insufficient welding.

The affected products are designed to be used with SmartLife Non-Sterile Batteries to power System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. The recall covers all lot numbers from 13072 to 14121. Distribution was worldwide, including the United States and countries such as Australia, Canada, Sweden, and Japan.

The FDA has classified this as a Class II recall. Users should stop using the affected housings and contact Stryker for instructions on return or replacement.

The recalled product

Product
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…
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 7222-120-000
  • All lot numbers from 13072 to 14121

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 →

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