Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2762-2016Class II

Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665

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

Riverpoint Medical, LLC began a recall of Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation... on . FDA classified it as Class II and gives the reason as "Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2762-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Riverpoint Medical, LLC
Product
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 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
Polypropylene 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
61 boxes distributed in the US only
Distribution
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Product codes and lots
Lot For Vet use: 160218-05V

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2762-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2761-2016Class IITerminatedVoluntary: Firm initiated
Z-2762-2016Class IITerminatedVoluntary: Firm initiated