FDA Device recall Z-2461-2025
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834 by Medtronic Xomed, citing due to out of the box wobble of the driver.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2461-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-17 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Xomed |
| Distribution | 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 |
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
Due to out of the box wobble of the driver.
Identifiers
| code_info | Product Number/Catalog: 230000 UDI-DI code: 00613994448705 Serial/Lot Numbers: PEU21207 PEU21208 PEU21210 PEU21211 PEU2…Product Number/Catalog: 230000 UDI-DI code: 00613994448705 Serial/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 PEU21269 PEU21270 PEU21273 PEU21274 PEU21277 PEU21278 PEU21279 PEU21285 PEU21286 PEU21294 PEU21296 PEU21297 PEU21299 PEU21301 PEU21302 PEU21305 PEU23001 PEU23003 PEU23004 PEU23005 PEU23009 PEU23010 PEU23013 PEU23015 PEU23016 PEU23024 PEU23027 PEU23031 PEU23044 PEU23049 PEU23050 PEU23051 PEU23052 PEU23053 PEU23054 PEU23055 PEU23056 PEU23057 PEU23058 PEU23059 PEU23060 PEU23061 PEU23062 PEU23063 PEU23064 PEU23071 PEU23072 PEU23073 PEU23074 PEU23075 PEU23076 PEU23077 PEU23078 PEU23079 PEU23080 PEU23083 PEU23086 PEU23087 PEU23088 PEU23089 PEU23098 PEU23099 PEU |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2461-2025%22
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