—#132898

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.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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.

Timeline

Recall initiated: 2015-01-07
Posted by FDA: 2015-02-09
Terminated: 2016-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132898. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.