Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
- Company
- American Medical Systems
- Recall Initiated
- July 28, 2003
- Posted
- July 20, 2004
- Terminated
- June 22, 2004
- Recall Number
- Z-1019-04
- Quantity
- 62 units
- Firm Location
- W Minnetonka, MN
Reason for Recall
Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.
Distribution
The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.
Lot / Code Info
Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
Root Cause
Other
Action Taken
The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.
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