SUTUREFIX Ultra S with 1 #2 Ultrabraid recall: Sterility Concern
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Why was SUTUREFIX Ultra S with 1 #2 Ultrabraid 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: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899
- Product
- SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 907 units
- 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)