FDA Medical Device Recalls (openFDA)
Zimmer Orthopaedic Surgical Products: Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual 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-0390-05
- Recalling firm
- Zimmer Orthopaedic Surgical Products
- Product
- Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual 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
- Total 45730 cuffs
- Distribution
- Nationwide, Australia, Demark, Germany
- Lot, serial or model codes
- Cat #60-7070-002-00, Lot #60156865. On 02/11/2005 the firm expanded the recall to include the following codes: Cat #60-7070-003-00, Lot #60154121, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60166017, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60135936, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60162824, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60161308, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60159350, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60173808, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60171347, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60171346, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60191896, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60180450, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60162831, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60184634, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60173807, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60194151, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60194152, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60188441, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60202399, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60176464, Dual Port Single, Bladder Cuff, Cat 360-7070-003-00, Lot #60205580, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60208192, Dual Port Single, Bladder Cuff, Cat #60-7070-002-00, Lot #60187086. Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60178439, Dual Port, Single Bladder Cuff,
- 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