Z-1822-2015Class II

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair

Name: Z-1822-2015 ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair
Creator: Smith & Nephew, Inc.
Published: 2015-04-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-04-30 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair on 2015-04-30. FDA classified it as Class II and gives the reason as "Sterility of device maybe compromised". 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-1822-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-30
Posted: 2015-06-22
Terminated: 2017-09-19
Recalling firm: Smith & Nephew, Inc.
Product: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Reason for recall: Sterility of device maybe compromised
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at [email protected] or fax +1-901-566-7975 to obtain a return authorization (RA) number
Quantity in commerce: 202,279 units
Distribution: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
Product codes and lots: All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code GAT

K132079Class IITfcc Fast-Fix KitSmith & Nephew, Inc. / cleared 2013-12-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)