Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-495-00, 10kits/package, Zimmer Orthopaedic Su
FDA device recall Z-0864-2008 · posted 2008-03-06 · Terminated
Recall details
- Recalling firm
- Zimmer Orthopaedic Surgical Products
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FQH
- Quantity affected
- 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 Rep
- Date initiated
- 2007-12-18
- Date posted
- 2008-03-06
- Date terminated
- 2012-05-03
- Location
- Dover, OH
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