System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
FDA Recall Z-1066-2015 · Posted 2015-02-09
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHWE
Date Initiated2015-01-07
Date Terminated2016-03-09
Product Quantity399
Reason for Recall
Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.
Firm Action
Stryker sent notice to customers via Fed ex overnight on 1/16/2015, regarding its voluntary recall of Stryker System 6 Aseptic Housings because the laser welder may have failed to produce a continuous bond line for the four specific lots: 13205, 13209, 13210, 13212. Customers are instructed to discontinue use, complete the business reply form, and return all recalled product. Customers may contact Kara Spath at 269-389-4518, or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AR, CA, CO, FL, GA, HI, MD, NC, NY, PA, SC, TX, and VA, and the countries of Australia, Canada, Switzerland, Hong Kong, South Africa, Chile, Korea, Poland, India, Colombia, The Netherlands, and France.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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