FDA Device recall Z-0646-2015
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267 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-0646-2015 |
| 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, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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 | 44278 44400 140839 140841 142634 143161 144272 246221 246222 246706 246708 344732 440763 444744 444746 4…44278 44400 140839 140841 142634 143161 144272 246221 246222 246706 246708 344732 440763 444744 444746 444747 444753 543666 543670 543676 642008 642014 642016 642021 642022 642023 647516 741834 741835 741839 741841 741842 741845 741850 742157 745055 745327 745636 746335 746336 746337 746338 746341 746348 746349 746352 746354 746979 844131 844181 844182 844184 844186 844192 844193 844196 844197 844198 844199 844201 844202 844305 844306 845990 845991 845992 845993 845995 845998 845999 846000 846001 846003 846004 846005 846006 846007 846008 846009 846010 846011 846012 846013 846014 864008 940460 940913 0943926E 0943927E 0943990E 0943991E 0943992E 0943993E 0943994E 0943995E 0943997E 0943999E 0944000E 0944001E 0944002E 0944003E 0944004E 0944006E 0944007E 0944008E 0944009E 0944010E 0944011E 0944013E 0944015E 0944016E 0944019E 0944021E 0944023E 0944025E 0944028E 0944031E 094403 |
|---|
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-0646-2015%22
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