XP-XP Tibial Tray - Interlok 71 mm
Medical device recall Z-2522-2019. Published in FDA’s Enforcement Report on Sep 18, 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 Sep 18, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 44 states named in where it went
- 1221 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?
The locking bar not fully engaging
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
1221 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number 450440 590880 512630 820720 820750 841600 841620 664320 841610 972770 589900 660500 664300 664310 677650 841580 664300R 972750 998070 758320 044000 841590 044020 066160 677640 066150 381750 420270 664330 381750R 381730 433990…
Every code shown here, 1,613 characters
Lot Number 450440 590880 512630 820720 820750 841600 841620 664320 841610 972770 589900 660500 664300 664310 677650 841580 664300R 972750 998070 758320 044000 841590 044020 066160 677640 066150 381750 420270 664330 381750R 381730 433990 374560 282790 374540 420280 433960 381740 358960 758290 468150 505080 036280 998080 089890 358970 374570 499170 505060 358970R 374570R 322450 282800 499150 420250 499160 499180 592370 468140 505070 592380 592350 322460 036270 505050 840730 885090 840710 855340 864720 885080 592360 592400 916860 958440 916850 828720 975610 958430 011470 023380 061400 061410 984770 181440 103040 181420 103030 131230 159310 061420 116010 116030 261080 293870 241450 297200 336140 293850 223150 241440 261090 384230 336980 337000 093400 223130 201950 297070 371590 336130 556580 587300 371560 418730 432380 384220 467200 511470 599810 599810R 634230 664180 684930 705650 715820 716100 715830 715840 715840R 882100 920600 906730 906720 029270 072940 985950 072920 126020 985940 396390 126010 163000 163010 247340 247360 247350 221400 293130 318540 293120 318530 336720 318510 336710 374470 374490 390050 318520 390070 570260 478910 478920 478940 441940 441950 441960 509740 543370 543350 509780 593630 625550 522640 576160 576170 593620 625570 639660 639670 670580 708620 670590 708540 741540 780230 758540 808280 522660 560360 780210 808300 570270 741530 758530 850950 850940 833190 873550 873540 917630 999330 999340 018150 999470 076700 111700 917640 943540 950970 999460 076690 111710 183520 481870 481880 559030 481880R 072650 137510 191160 219820 289240 562190 613400 650440 650450 422520
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.
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.
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.
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.
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.
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.