FDA Device recall Z-1883-2016
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only by Greatbatch Medical, citing greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1883-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-26 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greatbatch Medical |
| Distribution | IN, MI, TX |
Product
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
Reason
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
Identifiers
| code_info | 2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 62457800…2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 6245780001 6245790001 6245800001 6245810001 6245820001 6245830001 6245840001 6245850001 6245860001 6245870001 6245880001 6245890001 6245900001 6245910001 6245920001 6245930001 6245940001 6245950001 6245960001 6245970001 6245980001 6245990001 6246000001 6246010001 6246020001 6246030001 6246040001 6246050001 6246060001 6246070001 6246080001 6246090001 6246100001 6246110001 6246120001 6246130001 6246140001 6246150001 6246160001 6246170001 6246180001 6246190001 6246200001 6246210001 6246220001 6292870001 6420330001 6420340001 6422470001 6422480001 6422490001 6422500001 6422510001 6422520001 6422530001 6422540001 6422550001 6422560001 6441490001 6441500001 6448220001 6448230001 6448240001 6448250001 6448260001 6448270001 6448280001 6448290001 6448300001 6448310001 2091662 2091663 2091664 2091665 2091666 2091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1883-2016%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.