Device product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Z-0319-2025
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 95516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31,032 units
- Official record key
device-enforcement:Z-0319-2025
Official wording
Reason: Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Code information: UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Distribution pattern: International distribution to the country of China.
Derived failure modes
-
Unknown
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.