AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Ap
FDA device recall Z-0787-2007 · posted 2007-05-09 · Terminated
Recall details
- Recalling firm
- American Medical Systems
- Reason for recall
- The carton labeling does not match the product packaged inside.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JCW
- Quantity affected
- 1
- Distribution
- Worldwide, including USA, Canada and England.
- Date initiated
- 2007-02-09
- Date posted
- 2007-05-09
- Date terminated
- 2008-02-24
- Location
- Minnetonka, MN
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