SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue recallZ-2045-2014 · Smith & Nephew, Inc. Endoscopy Division · initiated Jun 2, 2014
Class II Terminated All recalls posted in July 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility of device is compromised due to breach in sterile barrier
FDA root cause category: Package design/selection
What the company is doing
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 [email protected]. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.
Recall details
- Recall number
- Z-2045-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 2, 2014
- Posted by the FDA
- Jul 14, 2014
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 259 units
- Product code
- MBI
- FDA submissions
- K122059
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Product description
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Code information (models, lots, serial numbers)
Lot Numbers: 50476555, 50481446
Other devices under the same FDA submission
1 device cleared under K122059 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 72203856Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 68565).
- Z-2046-2014 · TerminatedSUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
- Z-2047-2014 · TerminatedSUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
- Z-2048-2014 · TerminatedSUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
- Z-2049-2014 · TerminatedSUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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