Z-2761-2016Class II

Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product...

Name: Z-2761-2016 Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product...
Creator: Riverpoint Medical, LLC
Published: 2016-08-05
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2016-08-05 / Terminated / root cause: manufacturing process

FDA source

Riverpoint Medical, LLC began a recall of 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... on 2016-08-05. FDA classified it as Class II and gives the reason as "Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2761-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-05
Posted: 2016-09-08
Terminated: 2016-12-22
Recalling firm: Riverpoint Medical, LLC
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.
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 2110 boxes distributed in the US and 72 boxes distributed outside US
Distribution: US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Product codes and lots: Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2761-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2761-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2762-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code GAR

K100006Class IIHs Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/needRiverpoint Medical / cleared 2010-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)