FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
- Recall number
- Z-1822-2015
- Recalling firm
- Smith & Nephew, Inc.
- Product
- ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
- Status
- Terminated
- Initiated
- 2015-04-30
- Posted
- 2015-06-22
- Terminated
- 2017-09-19
- Reason
- Sterility of device maybe compromised
- Root cause
- Package design/selection
- Action
- Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number
- Quantity
- 202,279 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
- Lot, serial or model codes
- All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
- 510(k) numbers
- ["K132079"]
- PMA numbers
- not on file
- Product code
- GAT
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28