Smith & Nephew Suture Passer 2 inch Part Number : 7209167
FDA device recall Z-0726-2007 · posted 2007-04-07 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
- Action taken
- Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 12, 292 units for all recalls Z-0724-0726-07
- Distribution
- World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China.
- Date initiated
- 2007-03-01
- Date posted
- 2007-04-07
- Date terminated
- 2008-07-14
- Location
- Andover, MA
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