POWEREASE Instruments Set Screw Breakoff Instrument — Class II medical device recall Z-0952-2015
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2015-01-21, distributed in AR, CA, FL, GA, IA, KS, KY, MI…. The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper ma
| Recall number | Z-0952-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2014-12-03 |
| Classified | 2015-01-12 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-09-24 |
| Distributed | AR, CA, FL, GA, IA, KS, KY, MI, MS, NC, NY, OH, OR, PA, TX, WA |
| Quantity | 24 units |
| Lot numbers | CA14C107 |
| Model numbers | 2346010 |
Product
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Reason for recall
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
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-0952-2015. 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.