Recalls / —

—#121328

Product

BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K031685

Affected lot / code info

50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm

Smith & Nephew, Inc. Endoscopy Division

Address

150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.

Timeline

Recall initiated

2013-08-06

Posted by FDA

2013-09-17

Terminated

2016-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #121328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.