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Recall Observatory FDA recall evidence

Device product

BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor

Z-2217-2013

August 06, 2013

Class II

Product summary

Firm
Smith & Nephew, Inc. Endoscopy Division
Event
Event 66037
Status
Terminated
Classification
Class II
Quantity
1735 US
Official record key
device-enforcement:Z-2217-2013

Official wording

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

Code information: 50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630 50347152 50375169 50379044 50391248 50392390 50409415 50414558 50419568 50421350 50443184 50447005 50449127

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