Device Recall Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407266 의 리콜

Recall

57899

Class 2

Z-1830-2011

2011-02-03

2011-03-28

Terminated

United States

2011-06-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97708

The firm received five complaints that the stylet did not fit down the cannula. the investigation revealed that the incorrect probe assembly was packaged for two dekompressor part numbers with the lot number of 10214012.

Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, 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 inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.