Torque Limiting Screwdriver: Greatbatch Medical — Class II medical device recall Z-1883-2016
Terminated recall by Greatbatch Medical, reported 2016-06-08, distributed in IN, MI, TX. Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified thro
| Recall number | Z-1883-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greatbatch Medical, Plymouth, MN, United States |
| Recall initiated | 2016-04-26 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2018-06-07 |
| Distributed | IN, MI, TX |
| Countries outside the US | CH, DE, FR, IT |
| Quantity | 1,110 |
| Reason classes | sterility |
| Model numbers | 804-03-038, MTO35173505, MTO35173507, MTO35175303, MTO375173506, T11623, T14001, T14378, T14379, T14380, T8127 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1883-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.