FDA Device recall Z-0519-2020
Compress, Mini Compress
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Compress, Mini Compress by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0519-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
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.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | All lots manufactured between January 2008 - May 2019: 043240 073900 150190 236460 313350 391940 454660 4607…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 836 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0519-2020%22
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