FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
- Recall number
- Z-0413-03
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
- Status
- Terminated
- Initiated
- 2002-11-08
- Posted
- 2003-01-09
- Terminated
- 2005-04-20
- Reason
- Potential for non sterility as package tray does not contain aeration holes for ETO processing.
- 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
- 77 units
- Distribution
- Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,
- Lot, serial or model codes
- Lot Number: 552240
- 510(k) numbers
- ["K931621"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- 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