Device Recall Triathlon Femoral Distal Augment Left 의 리콜

Recall

64941

Class 2

Z-1370-2013

2013-03-25

2013-05-23

Terminated

United States

2015-05-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117473

Stryker orthopaedics received a report that a label on the external packaging (box) of a triathalon femoral distal augment 10mm- size 5 left depicted a glyph of an acetabular shell rather than a femoral distal augment. in addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.

The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.