Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual Port, Single Bladder Sterile, Zimmer, Dover, O
FDA device recall Z-0390-05 · posted 2005-01-12 · Terminated
Recall details
- Recalling firm
- Zimmer Orthopaedic Surgical Products
- Reason for recall
- The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
- Action taken
- Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KCY
- Quantity affected
- Total 45730 cuffs
- Distribution
- Nationwide, Australia, Demark, Germany
- Date initiated
- 2004-10-27
- Date posted
- 2005-01-12
- Date terminated
- 2005-12-20
- Location
- Statesville, NC
Monitor recalls programmatically
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