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Terminated

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

FDA Recall Z-0389-05 · Posted 2005-01-12

Recalling FirmZimmer Orthopaedic Surgical Products
Recall StatusTerminated
Product CodeKCY
Date Initiated2004-10-27
Date Terminated2005-12-20
Product Quantity42 units (10 cuffs per unit)

Reason for Recall

The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Demark, Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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