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.
FDA Recall Z-2761-2016 · Posted None
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Recalling FirmRiverpoint Medical, LLC
Recall StatusTerminated
Product CodeGAR
Date Initiated2016-08-05
Date Terminated2016-12-22
Product Quantity2110 boxes distributed in the US and 72 boxes distributed outside US
Reason for Recall
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Firm Action
Riverpoint Medical sent an Urgent Medical Device letter, dated August 5. 2016, and the Customer Response Form to their customers via email. The letter identified the affected product, problem and actions to be taken. Customers are instructed to check inventory, discontinue selling affected sutures and return affected devices to the firm. Distributors are instructed to notify their downstream customers. Consignees should submit the Customer Response Forms. For questions call Riverpoint Medical at 1-866-445-4929.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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