UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is
Medical device recall Z-0165-2015. Published in FDA’s Enforcement Report on Nov 12, 2014.
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 Nov 12, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 37 states named
- 828 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?
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
828, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946…
Every code shown here, 1,995 characters
89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946 222947 222948 222949 222950 222951 222952 222953 222955 222956 223077 223078 223079 223080 223081 223082 223083 223084 223085 223086 223199 223200 223201 223202 223203 223204 223205 223206 223207 223208 223209 223210 223401 223403 223404 223405 223406 223407 223408 223409 223410 223411 223730 223731 223732 223733 223734 223735 223736 223737 223738 223739 223804 224187 224188 224189 224190 224191 224192 224193 224194 224195 224196 224197 224198 224199 224200 224201 224202 224203 224204 224205 224206 224207 224208 224209 224210 224393 224394 224395 224396 224397 224398 224399 224400 224402 224625 224626 224627 224628 224629 224630 224631 224632 224633 224634 224635 224636 224637 224638 224639 224640 224641 224642 224643 224644 224645 224646 224647 224648 224815 224816 224819 224825 224997 224998 224999 225000 225001 225002 225003 225004 225005 225006 225007 225124 225125 225126 225127 225128 225129 225130 225131 225132 225133 225134 225135 225297 225298 225299 225301 225302 225303 225304 225305 225306 225307 225418 225419 225420 225421 225422 225423 225424 225425 225426 225427 225428 225429 225530 225531 225532 225533 225534 225535 225536 225537 225538 225539 225540 225554 225555 225556 225557 225558 225559 225560 225561 225563 225564 225565 225566 225567 225568 225569 225570 225571 225572 225573 225574 225575 225576 225577 226491 226492 226493 226494 226495 226496 226497 226498 226499 226500 226501 226502 226504 226511 226512 226513 226514 226515 226516 226517 226518 226519 226520 226521 226522 226523 226524 226525 226526 226527 226528 226529 226530 226531 226532 226533 226534 226535 226536 226537 226538 226539 226540 226541 226542 226543 226544 226545 226546 226547 226548 226549 226550 227582 227590 227594 227811 227820 227821…
FDA’s list runs to 9,106 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.
US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.
The states and territories these words name
37 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Oct 6, 2014.
- FDA classified it on Oct 31, 2014.
- FDA’s Enforcement Report published it on Nov 12, 2014.
- FDA terminated it on Apr 15, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Surgical Inc, of Dover, OH.
- 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 9,106 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
-
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.