Device Recall Stryker brand Neuroform 3 Microdelivery Stent System 의 리콜

Recall

65654

Class 2

Z-1808-2013

2013-06-24

2013-07-25

Terminated

United States

2013-09-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119819

The device is labeled incorrectly, in that, the device model number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. the model number on the outer box states upn m003e345020 (4.5mm x 20 mm neuroform 3 stent) while the pouch label states upn m003e3450300 (4.5mm x 30 mm neuroform 3 stent).

Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.