Z-0413-03

Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

Name: Z-0413-03 Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
Creator: Smith & Nephew, Inc.
Published: 2002-11-08
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2002-11-08 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725 on 2002-11-08. The reason FDA records is "Potential for non sterility as package tray does not contain aeration holes for ETO processing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0413-03
Status: Terminated
Initiated: 2002-11-08
Posted: 2003-01-09
Terminated: 2005-04-20
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
Product code: HRX Arthroscope
Reason for recall: Potential for non sterility as package tray does not contain aeration holes for ETO processing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.
Quantity in commerce: 77 units
Distribution: Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,
Product codes and lots: Lot Number: 552240

Product code HRX

K931621Class IIAcufex Pro-Pac and ISO-PacAcufex Microsurgical, Inc. / cleared 1994-01-21

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)