Recalls / —

—#121336

Product

OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor

FDA product code

JDR — Staple, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K082215

Affected lot / code info

50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064

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 #121336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.