Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to…
Medical device recall Z-0973-2019. Published in FDA’s Enforcement Report on Mar 13, 2019.
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 Mar 13, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 42 states named
- 14,265 units 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?
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
14,265 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000…
Every code shown here, 1,998 characters
Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000 375-951-000, 375-555-000 375-951-012, 375-562-000 375-951-100, 375-564-000 375-951-112, 375-565-000 375-951-200 and 375-747-000 375-952-000. Lots from affected catalog numbers: 4601435 7687551 7954336 8069955 8143951 8213505 8290940 4866597 7692818 7957638 8078776 8143979 8216233 8296920 5275122 7695149 7962443 8078965 8144105 8220563 8297887 5810401 7696653 7964118 8079076 8144770 8220748 8297970 6165680 7702505 7964966 8082376 8146583 8223629 8298035 6552450 7725942 7965089 8082638 8148337 8223910 8298128 6563177 7743624 7969196 8082746 8150492 8224388 8298625 6634381 7755555 7978089 8095770 8150617 8224621 8305181 6694100 7766506 7978931 8096123 8150664 8228215 8305467 6705350 7767267 7981959 8096255 8152993 8228340 8305524 6712065 7768175 7986332 8096613 8153141 8228408 8305595 6761681 7782229 7991417 8099709 8153248 8231445 8308196 6819315 7821595 7997091 8100287 8153419 8231599 8308261 7066139 7829681 8004687 8100406 8153658 8231736 8310523 7076865 7831750 8007843 8104913 8154010 8231864 8320330 7119659 7838095 8016985 8104966 8159807 8232000 8320617 7129915 7839027 8022071 8105004 8159895 8235618 8323092 7184490 7840722 8028142 8105058 8161407 8244348 8323194 7196683 7842014 8028208 8105299 8163785 8244353 8323457 7252265 7842476 8028220 8105378 8163860 8244492 8323899 7370055 7842578 8028556 8113641 8163873 8244519 8330243 7383670 7851733 8028637 8113734 8166754 8247857 8339095 7403808 7852107 8036566 8113809 8167287 8251682 8339146 7413359 7852182 8036815 8113845 8170405 8251719 8352883 7428476 7865156 8040157 8117025 8170763 8251844 8359800 7455721 7868429 8040323 8117115 8172102 8251994 8367003 7505081 7869132 8045052 8121520 8177364 8252345 8367185 7505505 7874618 8045121 8121667 8181204 8257718 8377347 7535206 7879255 8045270…
FDA’s list runs to 2,589 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.
Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. OUS Israel and Canada.
The states and territories these words name
42 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- 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.
The words say it went outside the United States too.
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 Jul 27, 2018.
- FDA classified it on Mar 5, 2019.
- FDA’s Enforcement Report published it on Mar 13, 2019.
- FDA terminated it on Sep 17, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 2,589 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.