FDA Device recall Z-0623-2015
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233 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-0623-2015 |
| 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, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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 | 42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 02…42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 0245381C 0245820C 0245821C 0245832C 0245891C 0246317C 0246318C 0246930C 0247039C 0247041C 3122014 0341227C 0341901C 0344750C 04192012E 04232013E 42499 04262013D 0442448C 0442451C 0442454C 0442457C 0442458C 0442460C 0442463C 0442465C 0442466C 0442467C 0442470D 05102011E 5132010 5262010 0541369D 0541374D 0541377D 0541381D 0541388D 0541390D 0541392D 0541393D 6022014 6142014 06182012E 6202014 6222014 6232014 0640125D 0640129D 0640131D 0640132D 0640133D 0640135D 0640137D 0640138D 0640140D 0640141D 0640146D 0640906D 0643123D 0643124D 0643125D 0643126D 0643127D 0643128D 0643130D 0643131D 0643134D 0643135D 0643136D 0643137D 0643138D 0643139D 0643140D 0646331D 0646997D 646998 0646998D 0646999D 0647000D 0647001D 0647002D 0647004D 0647006D 0647008D 0647009D 0647010D 0647012D 0647014D 0647015D 0 |
|---|
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-0623-2015%22
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