Recall Z-0672-2018 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
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.
| Date | Oct 23, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 148.913 |
| Distribution | China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983536 | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS Ethicon Endo-Surgery, Inc., Dec 18, 1998 |