Recall Z-0864-2008 ยท FQH Lavage, Jet
Zimmer Orthopaedic Surgical Products
Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-495-00, 10kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
| Date | Mar 6, 2008 (initiated Dec 18, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm. |
| Root cause | Other |
| Action | Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them. |
| Quantity | 3,842 kits |
| Distribution | Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.