FDA Device recall Z-0634-2015
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246 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-0634-2015 |
| 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, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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 | 140616 245976 340614 344497 444951 540952 643595 846782 847704 940162 941321 942551 943424 943445 943536…140616 245976 340614 344497 444951 540952 643595 846782 847704 940162 941321 942551 943424 943445 943536 943537 945451 1040934 1041474 1041845 1042234 1042681 1042691 1042707 1141159 1141977 1143134 1144330 1145150 1145799 1146352 1240419 1240501 1241813 1242394 1242476 1243369 1244536 1245518 1341465 1341598 1341600 1343695 1344290 1345041 1345100 1345606 1346109 1346670 1440677 1440707 1440894 1440896 |
|---|
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-0634-2015%22
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