IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834 — Class II medical device recall Z-2461-2025
Ongoing recall by Medtronic Xomed, Inc., reported 2025-09-03, distributed in AZ, CA, CO, CT, FL, GA, IA, IL…. Due to out of the box wobble of the driver.
| Recall number | Z-2461-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-08-27 |
| Reported by FDA | 2025-09-03 |
| Distributed | AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX |
| Countries outside the US | AE, CA, CH, CN, DE, ES, FR, GB, HR, IN, IT, JO, JP, KR, KW, NO, RO, SE, TR |
| Quantity | 214 |
| UPC / GTIN / UDI-DI | 00613994448705, 00643169406834 |
| Lot numbers | PEU21207, PEU21208, PEU21210, PEU21211, PEU21212, PEU21213, PEU21214, PEU21215, PEU21216, PEU21217, PEU21218, PEU21219, PEU21221, PEU21222, PEU21224, PEU21225, PEU21226, PEU21227, PEU21228, PEU21229, PEU21230, PEU21231, PEU21239, PEU21240, PEU21246, PEU21247, PEU21248, PEU21251, PEU21252, PEU21253, PEU21254, PEU21255, PEU21257, PEU21259, PEU21263, PEU21264, PEU21265, PEU21266, PEU21267, PEU21268 and 174 more |
| Model numbers | 230000, 2300000 |
Product
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Reason for recall
Due to out of the box wobble of the driver.
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-2461-2025. 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.