Date Initiated by Firm |
August 05, 2016 |
Create Date |
September 08, 2016 |
Recall Status1 |
Terminated 3 on December 22, 2016 |
Recall Number |
Z-2762-2016 |
Recall Event ID |
74891 |
510(K)Number |
K100006
|
Product Classification |
Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
|
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.
|
Code Information |
Lot For Vet use: 160218-05V |
Recalling Firm/ Manufacturer |
Riverpoint Medical, LLC 825 NE 25th Ave Portland OR 97232-2304
|
For Additional Information Contact |
Edwin Anderson 866-445-4929
|
Manufacturer Reason for Recall |
Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GAR and Original Applicant = RIVERPOINT MEDICAL
|