SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
FDA Recall Z-1048-03 · Posted 2003-07-24
Recalling FirmPower Medical Interventions
Recall StatusTerminated
Product CodeGAG
Date Initiated2003-06-30
Date Terminated2004-03-16
Product Quantity4211 units
Reason for Recall
latching mechanism failure
Firm Action
The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.
Root Cause
Other
Distribution Pattern
The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.