Class 2 Device Recall IPC Powerease System

• Date Initiated by Firm: July 17, 2025
• Date Posted: August 27, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2461-2025
• Recall Event ID: 97266
• 510(K)Number: K111520
• Product Classification: Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
• 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.
• Code Information: 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 PEU23100 PEU23101 PEU23105 PEU23106 PEU23107 PEU23108 PEU23109 PEU23110 PEU23111 PEU23112 PEU23125 PEU23126 PEU23127 PEU23133 PEU23134 PEU23135 PEU23136 PEU23140 PEU23142 PEU23143 PEU23146 PEU23149 PEU23159 PEU23160 PEU23161 PEU23163 PEU23164 PEU23165 PEU23166 PEU23167 PEU23170 PEU23171 PEU23172 PEU23175 PEU23176 PEU23177 PEU23178 PEU23179 PEU23180 PEU23181 PEU23182 PEU23183 PEU23196 PEU23197 PEU23198 PEU23199 PEU23207 PEU23208 PEU23210 PEU23215 PEU23216 PEU23218 PEU23220 PEU23221 PEU23222 PEU23223 PEU23224 PEU23225 PEU23229 PEU23230 PEU23231 PEU23235 PEU23249 PEU23251 PEU23253 PEU23268 PEU23277 PEU23278 PEU23281 PEU23282 PEU23283 PEU23288 PEU23289 PEU23291 PEU23292 PEU23293 PEU23303 PEU23304 PEU23305 PEU23306 PEU23310 PEU23311 PEU23312 PEU23313 PEU23314 PEU23316 PEU23317 PEU23318 PEU23319 PEU23322 PEU23323 PEU23324 PEU23325 PEU23326 PEU23327 PEU23338 PEU23339 UDI-DI code: 00643169406834 Serial/Lot Numbers: PEU23011 PEU23012 PEU23066 PEU23067 PEU23069 PEU23137 PEU23138 PEU23139 PEU23147 PEU23173 PEU23174 PEU23274 PEU23276 PEU23279 PEU23280
• FEI Number: 1045254
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: Rita Greenberg; 904-296-9600
• Manufacturer Reason for Recall: Due to out of the box wobble of the driver.
• FDA Determined Cause: Process change control
• Action: 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.
• Quantity in Commerce: 214
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HBE