Z-0949-2021Class II

Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm...

Name: Z-0949-2021 Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm...
Creator: Riverpoint Medical, LLC
Published: 2020-12-09
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2020-12-09 / Terminated / root cause: manufacturing process

FDA source

Riverpoint Medical, LLC began a recall of Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 on 2020-12-09. FDA classified it as Class II and gives the reason as "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...". 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-0949-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-09
Posted: 2021-02-03
Terminated: 2023-04-21
Recalling firm: Riverpoint Medical, LLC
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
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Lot # 19062715X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0949-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0949-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-03

Product code GAM

K120556Class IIVilet Vilet QuickRiverpoint Medical / cleared 2012-05-23

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)