Recall Z-0949-2021 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Riverpoint Medical, LLC
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
| Date | Dec 9, 2020 |
| Status | Terminated |
| Reason | 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 | 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 inform |
| Quantity | 3060 units |
| Distribution | US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120556 | VILET VILET QUICK Riverpoint Medical, May 23, 2012 |