Device product
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Z-0758-2021
Product summary
- Event
- Event 86880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 458 units
- Official record key
device-enforcement:Z-0758-2021
Official wording
Reason: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Code information: GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.
Distribution pattern: Distribution US nationwide and Japan.
Derived failure modes
-
Unknown
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.