OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture a

FDA device recall Z-2228-2013 · posted 2013-09-17 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

Reason for recall

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Action taken

Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.

Root cause

Packaging

Status

Terminated

Product code

JDR

Quantity affected

10296 US

Distribution

Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland,

Date initiated

2013-08-06

Date posted

2013-09-17

Date terminated

2016-04-20

Location

Andover, MA

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