Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA.
FDA device recall Z-0565-05 · posted 2005-02-25 · 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 notified by letter on 02/11/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- KCY
- Quantity affected
- Total 430 cuffs
- Distribution
- Nationwide
- Date initiated
- 2005-02-11
- Date posted
- 2005-02-25
- Date terminated
- 2006-04-07
- Location
- Statesville, NC
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