IPC Powerease System
Medical device recall Z-2461-2025. Published in FDA’s Enforcement Report on Sep 3, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 3, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 25 states named in where it went
- 214 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to out of the box wobble of the driver.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
214, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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…
FDA’s list runs to 2,052 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
25 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Louisiana
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oregon
- South Carolina
- Tennessee
- Texas
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 17, 2025.
- FDA classified it on Aug 27, 2025.
- FDA’s Enforcement Report published it on Sep 3, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Xomed, Inc., of Jacksonville, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,052 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.