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Terminated

Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)

FDA Recall Z-0725-2007 · Posted 2007-04-07

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeNBW
Date Initiated2007-03-01
Date Terminated2008-07-14
Product Quantity12, 292 units for all recalls Z-0724-0726-07

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.

Firm Action

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

Distribution Pattern

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. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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