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RecallWatchMedical Device Safety
Class IIOngoingZ-2461-2025

Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC P…

Medtronic Xomed, Inc.Jacksonville, FL, United StatesReported Sep 3, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

Due to out of the box wobble of the driver.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeCatalog # 230000
    215 affected lots
    PEU21207PEU21208PEU21210PEU21211PEU21212PEU21213PEU21214PEU21215
    +207 morePEU21216PEU21217PEU21218PEU21219PEU21221PEU21222PEU21224PEU21225PEU21226PEU21227PEU21228PEU21229PEU21230PEU21231PEU21239PEU21240PEU21246PEU21247PEU21248PEU21251PEU21252PEU21253PEU21254PEU21255PEU21257PEU21259PEU21263PEU21264PEU21265PEU21266PEU21267PEU21268PEU21269PEU21270PEU21273PEU21274PEU21277PEU21278PEU21279PEU21285PEU21286PEU21294PEU21296PEU21297PEU21299PEU21301PEU21302PEU21305PEU23001PEU23003PEU23004PEU23005PEU23009PEU23010PEU23013PEU23015PEU23016PEU23024PEU23027PEU23031PEU23044PEU23049PEU23050PEU23051PEU23052PEU23053PEU23054PEU23055PEU23056PEU23057PEU23058PEU23059PEU23060PEU23061PEU23062PEU23063PEU23064PEU23071PEU23072PEU23073PEU23074PEU23075PEU23076PEU23077PEU23078PEU23079PEU23080PEU23083PEU23086PEU23087PEU23088PEU23089PEU23098PEU23099PEU23100PEU23101PEU23105PEU23106PEU23107PEU23108PEU23109PEU23110PEU23111PEU23112PEU23125PEU23126PEU23127PEU23133PEU23134PEU23135PEU23136PEU23140PEU23142PEU23143PEU23146PEU23149PEU23159PEU23160PEU23161PEU23163PEU23164PEU23165PEU23166PEU23167PEU23170PEU23171PEU23172PEU23175PEU23176PEU23177PEU23178PEU23179PEU23180PEU23181PEU23182PEU23183PEU23196PEU23197PEU23198PEU23199PEU23207PEU23208PEU23210PEU23215PEU23216PEU23218PEU23220PEU23221PEU23222PEU23223PEU23224PEU23225PEU23229PEU23230PEU23231PEU23235PEU23249PEU23251PEU23253PEU23268PEU23277PEU23278PEU23281PEU23282PEU23283PEU23288PEU23289PEU23291PEU23292PEU23293PEU23303PEU23304PEU23305PEU23306PEU23310PEU23311PEU23312PEU23313PEU23314PEU23316PEU23317PEU23318PEU23319PEU23322PEU23323PEU23324PEU23325PEU23326PEU23327PEU23338PEU2333900643169406834PEU23011PEU23012PEU23066PEU23067PEU23069PEU23137PEU23138PEU23139PEU23147PEU23173PEU23174PEU23274PEU23276PEU23279PEU23280

What the firm is doing

On 07/17/2025, the firm initiated distribution of "URGENT: MEDICAL DEVICE RECALL" Letters via email and/or mail to customers informing them of reported out-of-box failures due to device wobble which is due to misalignment between the quick connect and shaft main driver components of the IPC Powerease System Model 2300000. Customers are instructed to: . Identify, segregate, quarantine and stop use of any affected products within your inventory. The list of affected device serial numbers is included in Attachment A: Product Serial Number List. . Your Medtronic field representative will coordinate the replacement of your affected product. . Return affected product in your inventory to Medtronic. Please see Customer Confirmation Form for instructions on returning impacted devices. . Please complete and return the customer confirmation form enclosed with this letter acknowledging receipt of this information via email to neuro.quality@medtronic.com even if you no longer have possession, custody, or control over the affected product. Note: Instructions on returning the acknowledgement form to Medtronic is located on the form itself. . Please share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records. For questions or assistance please contact Medtronic Sales Representative and/or Technical Services at 1-888-826-5603.

DistributionShow details

U.S.: 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, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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