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Recall Observatory FDA recall evidence

Device product

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

Z-0319-2025

September 25, 2024

Class II

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

    reason.no_named_rule · v1.0.0

    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.