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.
FDA Recall Z-1657-2008 · Posted 2008-09-16
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Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeHRX
Date Initiated2008-01-31
Date Terminated2011-01-08
Product Quantity2,129
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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