Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract…

Date

Feb. 28, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ethicon Endo-Surgery Inc

Product

Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Reason

There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

Distribution pattern

China

Quantity

148.913

Codes and lots

CCS25, CCS29

Recall started

Oct. 23, 2017

Device type

Staple, Implantable

Root cause (FDA)

Under Investigation by firm

What the company told customers

Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.

Recall number

Z-0672-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0672-2018. The agency record governs; check it and the company before acting.