AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Pe
FDA device recall Z-0789-2007 · 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
- 10
- 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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