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Recall Observatory FDA recall evidence

Device 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

Z-0949-2021

December 09, 2020

Class II

Product summary

Firm
Riverpoint Medical, LLC
Event
Event 87036
Status
Terminated
Classification
Class II
Quantity
3060 units
Official record key
device-enforcement:Z-0949-2021

Official wording

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.

Code information: Lot # 19062715X

Distribution pattern: US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error