Device Recall Stryker 의 리콜

Recall

65646

Class 2

Z-1846-2013

2013-05-21

2013-07-31

Terminated

United States

2014-10-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119805

Stryker osteosynthesis has become aware that left gamma3 nails are marked as right nails.

Stryker sent notification letters and product accountability forms dated May 21, 2013. via Fed Ex with return receipt to all branches/agencies and on May 22, 2013, via Fed Ex with return receipt to all hospital risk management, chief of orthoapedics, and surgeons. Our records indicate that you may have received and/or used the above referenced product(s). It is Stryker's¿¿ responsibility as the manufacturer to ensure that customers who may have received and/or used these affected products also receive this important communication. Please contact your Stryker¿¿ Sales Representative to arrange for return of the product if you have any of the above listed items. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 855- 251-3635. Please note that your signature on the following form only confirms that you received this notification and does not obligate you to take any additional action beyond what is called for in this notification letter. We regret any inconvenience this action may cause you and if you have any questions, please call (201) 972-2100.