Z-2166-2012Class II

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number...

Name: Z-2166-2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2012-07-03
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2012-07-03 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the... on 2012-07-03. FDA classified it as Class II and gives the reason as "Distal part of the anchor may break on insertion into bone during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2166-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Posted: 2012-08-09
Terminated: 2016-04-18
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Distal part of the anchor may break on insertion into bone during surgery
Root cause tag: design
FDA root cause: Device Design
Action: Smith & Nephew sent an Urgent Product Recall 1st Notification letters dated June 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to inspect inventory and quarantine them immediately, complete and return the attached form indicating the Lot# and quantities that need to be returned and contact Smith & Nephew Returns Group at 800-343-5717 (option 3) or email to [email protected]. for instructions for returning affected products and receiving a credit. For questions call 1-508-261-3731.
Quantity in commerce: 4,661 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
Product codes and lots: Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2165-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2166-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2167-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2168-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code MBI

K100159Class IISmith and Nephew Twinfix Ultra Ti Suture AnchorSmith & Nephew Inc., Endoscopy Div. / cleared 2010-04-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)