Z-0865-2008

Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic...

Name: Z-0865-2008 Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic...
Creator: Zimmer Orthopaedic Surgical Products
Published: 2007-12-18
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2007-12-18 / Terminated / root cause: packaging

FDA source

Zimmer Orthopaedic Surgical Products began a recall of Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio on 2007-12-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0865-2008
Status: Terminated
Initiated: 2007-12-18
Posted: 2008-03-06
Terminated: 2012-05-03
Recalling firm: Zimmer Surgical SA
Product: Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
Product code: FQH Lavage, Jet
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.
Root cause tag: packaging
FDA 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 in commerce: 607 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, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
Product codes and lots: Lot Numbers: 60626640, 60666511, 60709924, 60734619, and 60778405.

Product code FQH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)