FDA Device recall Z-0742-2015
PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipul…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipul… 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-0742-2015 |
| 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 INSERT, 45CM, PARK FORCEPS, P/N 0250080745 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 | 847473 847474 940102 941596 944715 1042915 1044422 1045480 1141153 1141784 1142923 1144956 1145808 1147035…847473 847474 940102 941596 944715 1042915 1044422 1045480 1141153 1141784 1142923 1144956 1145808 1147035 1244592 1343423 1343481 1343728 1344026 |
|---|
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-0742-2015%22
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