Z-0798-06

FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

Name: Z-0798-06 FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2006-03-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-03-24 / Terminated

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399 on 2006-03-24. The reason FDA records is "The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0798-06
Status: Terminated
Initiated: 2006-03-24
Posted: 2006-04-26
Terminated: 2007-12-12
Recalling firm: Smith & Nephew, Inc.
Product: FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
Product code: KGS Retention Device, Suture
Reason for recall: The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.
FDA root cause: Other
Action: Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.
Quantity in commerce: 1800 units
Distribution: Nationwide Foreign: Austria, Germany, France, Italy, Australia
Product codes and lots: Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381

Product code KGS

K020480Class IRbmSmith & Nephew, Inc. / cleared 2002-03-12

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)