Z-1657-2008

ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is...

Name: Z-1657-2008 ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is...
Creator: ArthroCare Corporation
Published: 2008-01-31
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2008-01-31 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation... on 2008-01-31. The reason FDA records is "Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure". 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-1657-2008
Status: Terminated
Initiated: 2008-01-31
Posted: 2008-09-16
Terminated: 2011-01-08
Recalling firm: ArthroCare Corporation
Product: ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures.
Product code: HRX Arthroscope
Reason for recall: Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Urgent Product Recall letters (Dated January 31, 2008) were issued to end users of the device (medical professionals) and direct distributors. The letter instructs users to return any affected products.
Quantity in commerce: 2,129
Distribution: Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and countries of Sweden, Australia, Germany, Italy, UK, Austria, Saudi Arabia, Belgium, Portugal, UAE, Kuwait, Singapore, Ireland, Spain, Finland, South Korea, Russia and Vietnam.
Product codes and lots: Lot Numbers: A603250-A, A609450-A, A610250-A, A615750-A, A616850-A, A627860-A, A627860-B, A604670-A, A615870-A, A620170-A, A623270-A, and A634670-A.

Product code HRX

K053567Class IIAthrocare Topaz ArthrowandsArthrocare Corp. / cleared 2006-03-06

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)