RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
FDA Recall Z-1912-2017 · Posted None
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeKDG
Date Initiated2017-03-30
Date Terminated2019-08-21
Product Quantity1004 units
Reason for Recall
The stability data does not support the product labeled with a 10-year shelf life.
Firm Action
The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.
Root Cause
Error in labeling
Distribution Pattern
Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.