FDA Device recall Z-0691-2015
PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342 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-0691-2015 |
| 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, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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 | 344320 542914 842447 843440 844144 844173 844321 844957 845072 846763 941831 942655 945439 1040398 104042…344320 542914 842447 843440 844144 844173 844321 844957 845072 846763 941831 942655 945439 1040398 1040425 1043259 1044647 1046103 1140613 1140855 1141922 1142930 1144227 1144948 1241790 1241791 1241945 1242479 1244068 1245027 1246068 1246193 1340477 1341248 1342749 1343416 1343711 1344464 1440436 1441385 |
|---|
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-0691-2015%22
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