Screwdriver Blade — Class II medical device recall Z-2189-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-07-20, distributed nationwide. DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and
| Recall number | Z-2189-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-05-31 |
| Classified | 2016-07-12 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 50 units |
| Reason classes | labeling |
| Lot numbers | 5053859 |
| Model numbers | 313.945 |
Product
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Reason for recall
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
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-2189-2016. 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.