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U.S. Department of Health and Human Services

Class 2 Device Recall VelosorbTM Fast Braided Absorbable Sutures

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  Class 2 Device Recall VelosorbTM Fast Braided Absorbable Sutures see related information
Date Initiated by Firm December 09, 2020
Create Date February 03, 2021
Recall Status1 Terminated 3 on April 21, 2023
Recall Number Z-0949-2021
Recall Event ID 87036
510(K)Number K120556  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Code Information Lot # 19062715X
Recalling Firm/
Manufacturer		 Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Doug King
503-517-8001
Manufacturer Reason
for Recall		 Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
FDA Determined
Cause 2		 Process control
Action On 12/11/2020, Riverpoint Medical issued a "Urgent: Medical Device Recall" notification via Email to affected consignees. In addition to informing consignees about the recall, Riverpoint asked consignees to take the following actions: 1. Immediately examine your inventory and quarantine product subject to the recall. 2. Discontinue selling product listed above (lot 19062715X) and return any existing stock to Riverpoint Medical. 3. Complete and return the enclosed response form as soon as possible to quality@rpmed.com. Mark the return shipments with RGA#12072020MDT 4. Provide recall information to any customers to whom you may have distributed or forwarded affected product. You may include a copy of this recall notice with your customer notification. 5. If you have any questions, call Riverpoint Medical at (503) 517-8001.
Quantity in Commerce 3060 units
Distribution US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
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 = GAM and Original Applicant = RIVERPOINT MEDICAL
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