FDA Medical Device Recalls (openFDA)
Zimmer Orthopaedic Surgical Products: Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit
- Recall number
- Z-0389-05
- Recalling firm
- Zimmer Orthopaedic Surgical Products
- Product
- Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit
- Status
- Terminated
- Initiated
- 2004-10-27
- Posted
- 2005-01-12
- Terminated
- 2005-12-20
- Reason
- The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
- Root cause
- Other
- Action
- Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
- Quantity
- 42 units (10 cuffs per unit)
- Distribution
- Nationwide, Australia, Demark, Germany
- Lot, serial or model codes
- Cat #60-7075-002-00, Lot #60153745
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 1035617
- Firm city
- Statesville
- Firm state
- NC
- 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