Recall Z-0173-2015 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Nov 5, 2014 (initiated Oct 8, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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.s |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.