Recall Z-0388-05 · KCY Tourniquet, Pneumatic
Zimmer Orthopaedic Surgical Products
Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), 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.
| Date | Jan 12, 2005 (initiated Oct 27, 2004) |
| Status | Terminated |
| 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 53100 cuffs |
| Distribution | Nationwide, Australia, Demark, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.