Z-1066-2015Class II

System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker...

Name: Z-1066-2015 System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-01-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-01-07 / Terminated / root cause: sterility

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered... on 2015-01-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1066-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Posted: 2015-02-09
Terminated: 2016-03-09
Recalling firm: Stryker Corp.
Product: 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.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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.
Root cause tag: sterility
FDA root cause: Under Investigation by 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].
Quantity in commerce: 399
Distribution: 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.
Product codes and lots: Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1066-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)