BIORAPTOR 2.9 mm Suture Anchor recall: Sterility Concern
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
Why was BIORAPTOR 2.9 mm Suture Anchor recalled?
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523
- Product
- BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 240 US
- Distribution
- 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.
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)