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Terminated

AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm product number 72404231. Penoscrotal Approach - with InhibiZone, 1 Pump, 2 Cylinders.

FDA Recall Z-0788-2007 · Posted 2007-05-09

Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeJCW
Date Initiated2007-02-09
Date Terminated2008-02-24
Product Quantity6

Reason for Recall

The carton labeling does not match the product packaged inside.

Firm Action

AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada and England.

Official Source

View FDA Recall →

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

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