FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
- Recall number
- Z-2049-2014
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
- Status
- Terminated
- Initiated
- 2014-06-02
- Posted
- 2014-07-14
- Terminated
- 2017-09-15
- Reason
- Sterility of device is compromised due to breach in sterile barrier
- Root cause
- Package design/selection
- Action
- Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.
- Quantity
- 763 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- Lot, serial or model codes
- Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684
- 510(k) numbers
- ["K122059"]
- PMA numbers
- not on file
- Product code
- MBI
- 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