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Recall Observatory FDA recall evidence

Device product

BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor

Z-2218-2013

August 06, 2013

Class II

Product summary

Firm
Smith & Nephew, Inc. Endoscopy Division
Event
Event 66037
Status
Terminated
Classification
Class II
Quantity
725 US
Official record key
device-enforcement:Z-2218-2013

Official wording

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

Code information: 50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571

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