Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Elect

FDA device recall Z-2145-2012 · posted 2012-08-03 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

Reason for recall

Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.

Action taken

Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. They will provide customers with instructions for returning affected products and receiving a credit. Each OUS affiliate shall be notified via (email or equivalent) of the recall by Smith & Nephew Inc.; the affiliate must then notify each facility affected by the recall. For question concerning this recall call 405-917-8585 or 978-749-1630.

Root cause

Error in labeling

Status

Terminated

Product code

GEI

Quantity affected

108 units

Distribution

Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.

Date initiated

2012-07-14

Date posted

2012-08-03

Date terminated

2021-03-22

Location

Andover, MA

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