SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture recall: Sterility Concern
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Why was SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture recalled?
Sterility of device is compromised due to breach in 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?
Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589
- Product
- SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 1086 untis
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- Recall date
- July 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)