FDA Device recall Z-0683-2015
PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320 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-0683-2015 |
| 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, STRONG FORCEPS, FENESTRATED, P/N 0250080320. 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 | 840362 842132 847517 1040110 1040420 1042259 1042934 1045030 1045283 1046905 1141972 1143003 1144487 11450…840362 842132 847517 1040110 1040420 1042259 1042934 1045030 1045283 1046905 1141972 1143003 1144487 1145075 1145230 1145347 1147038 1240535 1242461 1243537 |
|---|
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-0683-2015%22
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