Reported Sep 3, 2025 · Ongoing
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- IPC Powerease System REF 2300000 UDI-DI00613994448705 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
- Lot codes and dates
- Product Number/Catalog230000
- UDI-DI code00613994448705
- Serial/Lot Numbers
196 of 196 codes
PEU21207PEU21208PEU21210PEU21211PEU21212PEU21213PEU21214PEU21215PEU21216PEU21217PEU21218PEU21219PEU21221PEU21222PEU21224PEU21225PEU21226PEU21227PEU21228PEU21229PEU21230PEU21231PEU21239PEU21240PEU21246PEU21247PEU21248PEU21251PEU21252PEU21253PEU21254PEU21255PEU21257PEU21259PEU21263PEU21264PEU21265PEU21266PEU21267PEU21268PEU21269PEU21270PEU21273PEU21274PEU21277PEU21278PEU21279PEU21285PEU21286PEU21294PEU21296PEU21297PEU21299PEU21301PEU21302PEU21305PEU23001PEU23003PEU23004PEU23005
- PEU23327 PEU23338 PEU23339 UDI-DI code00643169406834
- Serial/Lot Numbers
PEU23011PEU23012PEU23066PEU23067PEU23069PEU23137PEU23138PEU23139PEU23147PEU23173PEU23174PEU23274PEU23276PEU23279PEU23280
- Amount recalled
- 214
Where it was sold
Why it was recalled
Due to out of the box wobble of the driver.
This product could cause temporary or reversible health problems — stop using it.
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