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Recall Observatory FDA recall evidence

Device product

PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

Z-1571-2023

March 31, 2023

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 92084
Status
Ongoing
Classification
Class II
Quantity
1,656 eaches (OUS only)
Official record key
device-enforcement:Z-1571-2023

Official wording

Reason: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

Code information: UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

Distribution pattern: International distribution in the countries of United Kingdom, Ireland and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved