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Recall Observatory FDA recall evidence

Device product

Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Z-2761-2016

August 05, 2016

Class II

Product summary

Firm
Riverpoint Medical, LLC
Event
Event 74891
Status
Terminated
Classification
Class II
Quantity
2110 boxes distributed in the US and 72 boxes distributed outside US
Official record key
device-enforcement:Z-2761-2016

Official wording

Reason: Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

Code information: Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01

Distribution pattern: US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.