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Terminated

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)

FDA Recall Z-1910-2017 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeKDG
Date Initiated2017-03-30
Date Terminated2019-08-21
Product Quantity1416 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.

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