Recall Z-1698-2009 ยท FQH Lavage, Jet
Zimmer Inc.
Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.
| Date | Jul 23, 2009 (initiated Jun 8, 2009) |
| Status | Terminated |
| Reason | The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility. |
| Root cause | Packaging process control |
| Action | Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974. |
| Quantity | 15 |
| Distribution | Worldwide Distribution -- United States, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.