Device product
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Z-0757-2021
Product summary
- Event
- Event 86880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 458 units
- Official record key
device-enforcement:Z-0757-2021
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 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.
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.