AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.
- Company
- American Medical Systems
- Recall Initiated
- February 9, 2007
- Posted
- May 9, 2007
- Terminated
- February 24, 2008
- Recall Number
- Z-0789-2007
- Quantity
- 10
- Firm Location
- W Minnetonka, MN
Reason for Recall
The carton labeling does not match the product packaged inside.
Distribution
Worldwide, including USA, Canada and England.
Lot / Code Info
Lot # 474230
Root Cause
Other
Action Taken
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.
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