FDA Medical Device Recalls (openFDA)
Zimmer Orthopaedic Surgical Products: Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
- Recall number
- Z-0862-2008
- Recalling firm
- Zimmer Orthopaedic Surgical Products
- Product
- Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
- Status
- Terminated
- Initiated
- 2007-12-18
- Posted
- 2008-03-06
- Terminated
- 2012-05-03
- 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
- 8,990 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
- Lot, serial or model codes
- Lot Numbers: 60613033, 60630005, 60650392, 60656855, 60666509, 60693324, 60694281, and 60703308.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQH
- Firm FEI
- 1526350
- Firm city
- Dover
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28