Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H 의 리콜

Recall

57292

Class 2

Z-0815-2011

2010-11-01

2010-12-27

Terminated

United States

2014-03-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95764

The cuttingedge advantage rasp handle, straight rasp handle, and specialty head center accolade broach handle may fracture in two pieces along the width of the body under the striking plate. this may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.

Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.