Device Recall Distal Centralizer Exeter II Hip System 의 리콜

Recall

55199

Class 2

Z-1601-2010

2010-03-29

2010-05-13

Terminated

United States

2012-09-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90282

Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.