FDA Medical Device Recalls (openFDA)
Riverpoint Medical, LLC: 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.
- Recall number
- Z-2761-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-08-05
- Posted
- not on file
- Terminated
- 2016-12-22
- Reason
- Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
- 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
- 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.
- Lot, serial or model codes
- Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01
- 510(k) numbers
- ["K100006"]
- PMA numbers
- not on file
- Product code
- GAR
- Firm FEI
- 3006981798
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28