Recall Z-1278-2019 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
| Date | Apr 11, 2019 |
| Status | Completed |
| Reason | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Root cause | Under Investigation by firm |
| Action | The firm, ETHICON, sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" letters to US customers beginning 4/11/19. The letters described the product, problem and actions to be taken. The customers were instructed to the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall (removal). 3. It is not necessary to contact your end customers regarding this action. Ethicon will directly communicate with customers about the above listed product subjec |
| Quantity | 434,614 total |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, |
| 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 |