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Endo GIA 60 mm Articulating Medium/Thick Reload with… recallZ-2504-2018 · Covidien Medtronic · initiated May 22, 2018

Class II Open, Classified All recalls posted in July 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien Medtronic or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

FDA root cause category: Process control

What the company is doing

On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: [email protected] or fax to (800) 895-6140. *Product purchased through distributor: [email protected] or fax it to (203) 492-7719.

Recall details

Recall number
Z-2504-2018
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 22, 2018
Posted by the FDA
Jul 19, 2018
Recalling firm
Covidien Medtronic
Product code
GDW
FDA submissions
K111825
Distribution
Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom

Product description

Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT

Code information (models, lots, serial numbers)

N7L0711KX, N7L1141KX, N7M0853KX, N8B0419KX, N7L0912KX, N7M0241KX, N8A0271KX, N8C0012KX, N7L0973KX, N7M0353KX, N8A0684KX, N8C0143KX, N7L1038KX, N7M0366KX, N8A0924KX, N7M0996KX, N7L0807KX, N7M0548KX, N8A1143KX, N8A0173KX,  N7L1050KX, N7M0617KX, N8B0161KX, N8A0488KX, N7L1125KX, N7M0745KX, N8B0283KX & N8C0136KX

Other devices under the same FDA submission

77 devices cleared under K111825 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80423).

Sources and updates

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