FDA Device recall Z-0650-2015
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280 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-0650-2015 |
| 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, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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 | 44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425…44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425 943746 944668 944833 945446 1040593 1040936 1041993 1042655 1042656 1042657 1142000 1142622 1142919 1143080 1143700 1143975 1144397 1144619 1144992 1146362 1240537 1241178 1241457 1243803 1244170 1244532 1245025 1245026 1341526 1341994 1342762 1344294 1344877 1440444 1442629 1443580 645726 |
|---|
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-0650-2015%22
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