Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff, 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-0565-05 · Posted 2005-02-25

Recalling FirmZimmer Orthopaedic Surgical Products
Recall StatusTerminated
Product CodeKCY
Date Initiated2005-02-11
Date Terminated2006-04-07
Product QuantityTotal 430 cuffs

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 notified by letter on 02/11/2005.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

↑