Device Recall Stryker Medical 1037 Trauma 의 리콜

Recall

59214

Class 2

Z-2923-2011

2011-07-19

2011-08-03

Terminated

United States

2013-08-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102063

Stryker medical has determined that some prime brake pad assembly components were manufactured with brake shoes that did not meet specifications. accordingly some brake shoes used within the prime brake pad assembly may wear prematurely, over the life of the product. reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.