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Recall Observatory FDA recall evidence

Device product

Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues

Z-0347-2014

December 13, 2012

Class II

Product summary

Firm
Riverpoint Medical, LLC
Event
Event 65584
Status
Terminated
Classification
Class II
Quantity
1932 pieces
Official record key
device-enforcement:Z-0347-2014

Official wording

Reason: Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

Code information: Lot 120716-01

Distribution pattern: US Distribution in the states of: AZ, FL, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.