Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall Z-0861-2008 · Posted 2008-03-06

Recalling FirmZimmer Orthopaedic Surgical Products
Recall StatusTerminated
Product CodeFQH
Date Initiated2007-12-18
Date Terminated2012-05-03
Product Quantity8,654 kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑