FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: 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.
- Recall number
- Z-1657-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-01-31
- Posted
- 2008-09-16
- Terminated
- 2011-01-08
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K053567"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3010813691
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28