Hearth Record

XP-XP Tibial Tray - Interlok 67 mm

Medical device recall Z-2524-2019. Published in FDA’s Enforcement Report on Sep 18, 2019.

FDA’s own record, on accessdata.fda.gov

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 18, 2019. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

The locking bar not fully engaging

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

XP-XP Tibial Tray - Interlok 67 mm Item # 195753

1210 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Lot Number 562170 613350 677700 677680 664240 758250 758230 753770 753780 998030 753790 590830 590840 660470 660480 664230 664260 664270 677660 677670 677710 590830R 677660R 677670R 972690 758210 972710 206980 174950 174950R 174960 206970…

Every code shown here, 1,265 characters

Lot Number 562170 613350 677700 677680 664240 758250 758230 753770 753780 998030 753790 590830 590840 660470 660480 664230 664260 664270 677660 677670 677710 590830R 677660R 677670R 972690 758210 972710 206980 174950 174950R 174960 206970 258000 258010 664290 664290R 664280 206960 282720 322360 468220 036240 219760 336620 359230 358920 592270 336640 592260 592260R 592230 592240 592250 592220 282740 322380 468230 358930 864700 802030 885040 802030R 802020 828700 828700R 975580 958380 840680 855270 011430 023360 061360 592200 916830 131190 093380 201930 223080 241430 103010 181390 159290 984750 297170 115960 261150 293750 958370 261160 336090 418680 432510 061340 587260 511450 599740 705580 634170 705560 664160 684880 715770 715750 716070 715760 716050 882070 985900 029240 906680 920570 029230 125980 396320 221370 072850 162930 162950 247270 247300 293090 318450 318460 336680 374390 374410 389960 441900 478840 478850 441890 298480 467170 509670 543250 543280 509690 576120 576110 593580 625460 639630 670540 708420 570220 741490 758500 570210 741500 780180 450420 522610 450420R 808210 833170 850900 850910 873500 873510 943520 999300 917610 950930 999430 183390 559010 560320 018100 111650 076660 191120 137490 422500 512600 650400 650410 571160 589780

Source:

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.

State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY

The states and territories these words name

44 states and territories.

Every one of them
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Florida
  • Georgia
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • Nebraska
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
  • West Virginia
  • Wyoming

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Aug 15, 2019.
  • FDA classified it on Sep 12, 2019.
  • FDA’s Enforcement Report published it on Sep 18, 2019.
  • FDA terminated it on Apr 16, 2021.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Zimmer Biomet, Inc., of Warsaw, IN.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

1 of 4

Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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