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Terminated

AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.

FDA Recall Z-0787-2007 · Posted 2007-05-09

Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeJCW
Date Initiated2007-02-09
Date Terminated2008-02-24
Product Quantity1

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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