FDA Device recall Z-0762-2015
PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma… by Stryker Endoscopy, citing the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0762-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-17 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
Product
PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Reason
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Identifiers
| code_info | 746665 747489 841837 847462 943678 1041060 1042953 1043059 1046383 1341551 1341979 1343418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0762-2015%22
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