Recall Z-0413-03 ยท HRX Arthroscope
Smith & Nephew, Inc.
Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
| Date | Jan 9, 2003 (initiated Nov 8, 2002) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931621 | ACUFEX PRO-PAC AND ISO-PAC Acufex Microsurgical, Inc., Jan 21, 1994 |