Z-2047-2014Class II

SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue)

Name: Z-2047-2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue)
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2014-06-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-06-02 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue on 2014-06-02. FDA classified it as Class II and gives the reason as "Sterility of device is compromised due to breach in sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2047-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Posted: 2014-07-14
Terminated: 2017-09-15
Recalling firm: Smith & Nephew, Inc.
Product: SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Sterility of device is compromised due to breach in sterile barrier
Root cause tag: packaging
FDA 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 [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.
Quantity in commerce: 907 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Product codes and lots: Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2047-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14
Z-2046-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14
Z-2047-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14
Z-2048-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14
Z-2049-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14

Product code MBI

K122059Class IIAll-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture AnchorsSmith & Nephew, Inc. / cleared 2013-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)