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

FDA device recall Z-1066-2015 · posted 2015-02-09 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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 kara.spath@stryker.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HWE

Quantity affected

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, S

Date initiated

2015-01-07

Date posted

2015-02-09

Date terminated

2016-03-09

Location

Portage, MI