FDA Device recall Z-0720-2015
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating… 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-0720-2015 |
| 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, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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 | 41466 41467 41729 41883 41892 42212 42256 42312 42811 43249 44279 70809 71009 71309 72209 80409 804092…41466 41467 41729 41883 41892 42212 42256 42312 42811 43249 44279 70809 71009 71309 72209 80409 804092 90809 1008091 1008092 1008093 1008094 1008095 100909 1112011 01112011A 01112011D 141531 141532 142480 142481 142482 143197 143208 0200178B 0200199C 0200200C 02022012E 2132014 02202013E 0244651B 0244851C 0244852C 0244853C 0245331C 0245528C 0245530C 0245531C 0245836C 0245837C 0245838C 0246753C 0246957C 0246958C 0246960C 0247433C 3012011 0341069C 0341543C 0341544C 0341916C 0341917C 0341919C 3419210 0344507C 0344509C 0344513C 0344515C 0344516C 0344519C 0344522C 0344523C 0344526C 0344527C 4012014 040313D 04122011E 04122011T 0443870C 0443871C 0443873C 0443874C 0443875C 0443876C 0443878C 0443879C 0443884D 0443886D 0443887D 0443888D 0443889D 0443890D 0443891D 0443893D 0445107C 5062010 51120102 05162013D 0542119D 0542336D 0542337D 0542338D 0542440D 0542447D 0542449D 0542450D 0542556D 0542 |
|---|
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-0720-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.