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Recall Observatory FDA recall evidence

Device product

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

Z-2219-2013

August 06, 2013

Class II

Product summary

Firm
Smith & Nephew, Inc. Endoscopy Division
Event
Event 66037
Status
Terminated
Classification
Class II
Quantity
240 US
Official record key
device-enforcement:Z-2219-2013

Official wording

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

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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier