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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker SmartLife Large Aseptic Housing

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  Class 2 Device Recall Stryker SmartLife Large Aseptic Housing see related information
Date Initiated by Firm October 08, 2014
Date Posted November 05, 2014
Recall Status1 Terminated 3 on May 31, 2016
Recall Number Z-0172-2015
Recall Event ID 69382
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
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 Handpiece.
Code Information Part Number 7126-120-000; All lot numbers from 13027 to 14093
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Process control
Action On October 8, 2014, Stryker Instruments issued "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to their consignees. Notification included affected product description, reason for recall, risk to health, and actions to be taken by the customer/user. The customer/user were instructed to immediately review this recall notification, check all stock areas; discontinue use of any product which shows sign of cracking or damage at the weld; and complete and return the enclosed Business Reply Form (BRF) via fax to Stryker Instruments Regulatory Department, 866-521-2762 or scan and email a copy to kara.spath@stryker.com. Upon receipt of completed BRF, a replacement product will be shipped and the customer/users, upon receipt of replacement product, are to remove and return all recalled product from use and replace them with new product. For questions regarding this recall, please contact Stryker Instruments: at 269-389-4518 or email: kara.spath@stryker.com.
Quantity in Commerce 3,138 in total
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.