Device recall: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft…
Class II FDA enforcement event 68565. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Sterility of device is compromised due to breach in sterile barrier
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Smith & Nephew, Inc. Endoscopy Division started this device recall on 2 Jun 2014. The firm address in the FDA record is in Andover, MA. FDA put the recall in Class II. FDA event 68565 has 5 product records. The first FDA enforcement report date is 23 Jul 2014. The record gives the status Terminated, with the termination date 15 Sep 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Recalling firm
Smith & Nephew, Inc. Endoscopy Division, Andover, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2045-2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue | 259 units | Class II | Terminated | 23 Jul 2014 |
| Z-2046-2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue | 136 units | Class II | Terminated | 23 Jul 2014 |
| Z-2047-2014 | SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue | 907 units | Class II | Terminated | 23 Jul 2014 |
| Z-2048-2014 | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue | 1086 untis | Class II | Terminated | 23 Jul 2014 |
| Z-2049-2014 | SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue | 763 units | Class II | Terminated | 23 Jul 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Aug 2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor | Device | Class II | 26 |
| 14 Jul 2012 | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: T | Device | Class II | 2 |
| 3 Jul 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Pr | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-2045-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 68565. https://recallregister.com/fda/ii/68565/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- What quantity of product is in FDA event 68565?
- The event has 5 product records. The first record gives this quantity:
259 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.