AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
- Company
- American Medical Systems
- Recall Initiated
- April 29, 2004
- Terminated
- October 31, 2005
- Recall Number
- Z-0930-04
- Quantity
- 5 units
- Firm Location
- W Minnetonka, MN
Reason for Recall
The product is mislabeled as to length.
Distribution
The affected products were distributed to consignees in the States of California and Texas, in Puerto Rico, and in the countries of Costa Rica and Taiwan.
Lot / Code Info
Lot/serial number 361100/001-005
Root Cause
Other
Action Taken
Recall letters, dated April 29, 2004, state that it is important for the consignees to contact the firm's customer service for an exchange of the recalled products for new product. The letters recommend that the consignees send an attached letter to physicians who implanted the products.
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