Compress, Mini Compress
Medical device recall Z-0519-2020. Published in FDA’s Enforcement Report on Dec 4, 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 Dec 4, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 219988 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?
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
219988 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All lots manufactured between January 2008 - May 2019: 043240 073900 150190 236460 313350 391940 454660 460760 482880 498540 512280 544320 545330 633210 670360 762790 792260 792270 817590 921680 985030 985860 008330 008330R 107310 156490…
Every code shown here, 1,999 characters
All lots manufactured between January 2008 - May 2019: 043240 073900 150190 236460 313350 391940 454660 460760 482880 498540 512280 544320 545330 633210 670360 762790 792260 792270 817590 921680 985030 985860 008330 008330R 107310 156490 181250 281130 310670 402480 501260 545340 545350 549190 678780 679390 720050 720060 755070 791580 816580 825010 954670 985290 989140 001130 039840 046290 114960 133540 157890 167740 177680 181260 199190 238670 242920 269770 281220 310920 428030 451480 465720 510770 510900 599300 696350 792280 821150 829820 830280 859420 921610 927330 947420 953480 010170 025880 046300 097120 133560 134450 157900 160130 177720 199200 206870 242580 281230 292790 310930 322360 349010 398080 428060 445800 445800R 477570 483190 495580 523750 588500 594850 599390 600450 615330 661100 696360 699090 715650 725930 730880 735850 794270 805190 821160 821960 836980 848500 864780 913390 925600 932080 932110 940500 947430 953490 953500 956980 958300 970180 993510 461290 461320 461330 807860 013580 017420 046280 046310 051290 056130 101630 134480 148320 157910 160140 178700 190510 199210 213830 214000 215840 217630 222400 242590 269780 279610 281250 292800 297290 305460 310950 348730 368120 384200 395710 395720 407270 409460 433130 454260 465450 508820 510910 523770 528600 531950 542190 559600 592990 593620 599410 603490 624040 647070 661110 667670 668880 671880 696370 706600 717020 742360 767240 771950 780790 803160 805200 821170 825060 864340 897610 902530 927380 940600 953510 957000 979870 980790 993520 997450 097130 156510 172900 354970 410340 427350 454640 457310 510920 549370 620980 696380 927860 971560 106160 156540 170710 209090 281290 295570 410350 410350R 414460 425010 460770 511140 523780 549380 596760 608580 618380 681060 696390 779820 897370 897650 952990 997920 007490 013540 026470 031560 098300 161050 222770 242640 242640R 242650 281300 311020 318200 319770 319770R 387180 395730 410360 415270 418850 425030 427360 439360 502600 510930 517230 523790…
FDA’s list runs to 22,546 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 and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
These words name no state.
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 Aug 21, 2019.
- FDA classified it on Nov 22, 2019.
- FDA’s Enforcement Report published it on Dec 4, 2019.
- FDA terminated it on Jul 21, 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.”
- FDA’s list of codes runs to 22,546 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.