Recall Z-0672-2018
Ethicon Endo-Surgery Inc · initiated October 23, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: CCS25, CCS29
Reason for recall
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0672-2018
- Initiated
- October 23, 2017
- Terminated
- July 18, 2019
- Product code
- GDW – Staple, Implantable
- Quantity
- 148.913
- Distribution
- China
- Recalling firm
- Ethicon Endo-Surgery Inc, Blue Ash, OH