Torque Limiting Adapter: Torque Limiting Attachment — Class II medical device recall Z-1884-2016
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-1884-2016 |
|---|---|
| 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 | 5,952 |
| Reason classes | sterility |
| Model numbers | 00-2360-080-00, 00-2360-080-05, MAC21001, MAC21003, T10232, T10233, T112972, T116245, T116430, T13621, TLA025-20, TLA025-25, TLA025-30 |
Product
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
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
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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.