FDA Device recall Z-0793-2015
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding,…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding,… by Stryker Endoscopy, citing stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 100….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0793-2015 |
| 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, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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
Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because 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 | 344341 645048 747480 844600 845063 845064 940134 941381 1041618 1042438 1042919 1042920 1044110 1044419 1…344341 645048 747480 844600 845063 845064 940134 941381 1041618 1042438 1042919 1042920 1044110 1044419 1045073 1046405 1144340 1146405 1147034 1241937 1242712 1244995 1342775 1343391 1344025 1344304 1344523 1344871 1344986 1344987 1346214 1346429 1346540 1346683 1440427 1442171 1443413 1443581 |
|---|
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-0793-2015%22
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