Z-0421-2011

Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture...

Name: Z-0421-2011 Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2010-10-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-10-14 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture retention device to facilitate percutaneous or... on 2010-10-14. The reason FDA records is "FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation". 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-0421-2011
Status: Terminated
Initiated: 2010-10-14
Posted: 2010-11-18
Terminated: 2012-05-09
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Reason for recall: FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
Root cause tag: design
FDA root cause: Device Design
Action: Smith & Nephew notified customers by an Urgent - Product Recall 1st Notification - Urgent letter sent via Federal Express October 14, 2010. The letter identified the affected product and explained the problem. The letter asked customers to call for a Return Authorization (RA) Number. Customers are to complete the form and return of the affected product along with a copy of the letter to the address provided being sure to reference the RA number. Questions were to be directed to Cindy Burns at 508-261-3655. Consignees out side the US were notified by e-mail.
Quantity in commerce: 130 units
Distribution: Worldwide Distribution - USA, Dubai, and Great Britain.
Product codes and lots: Lot Numbers: 50327272, 50327427, 50327430, and 50328898.

Product code GAT

K092508Class IIFast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,fast Fix 360 Ab Meniscal Repair System, Straight,Smith & Nephew, Inc. / cleared 2010-01-28

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)