Recall Z-0347-2014— Riverpoint Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Riverpoint Medical, LLC, initiated 2012-12-13, terminated 2013-11-21. It names one FDA 510(k) clearance: K100461. 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. 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..
- Recalling firm
- Riverpoint Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-13
- Terminated
- 2013-11-21
- Firm location
- Portland, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.