Recall Z-1048-03 ยท GAG Stapler, Surgical
Power Medical Interventions
SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
| Date | Jul 24, 2003 (initiated Jun 30, 2003) |
| Status | Terminated |
| Reason | latching mechanism failure |
| Root cause | Other |
| 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. |
| Quantity | 4211 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003277 | SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 Powermed, Inc., Dec 21, 2000 |