FDA Device recall Z-0777-2015
PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipu…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipu… 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-0777-2015 |
| 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, HOOK SCISSORS, 29CM, P/N 0250282049 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 | 643889 845498 846278 848131 1041615 1042530 1043321 1043534 1044413 1044450 1046413 1140170 1241796 1344964 1345084 |
|---|
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-0777-2015%22
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