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
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling Compress and Mini Compress surgical devices due to elevated levels of bacterial endotoxin and residual debris remaining on the devices as a result of a cleaning issue. The recall affects 219,988 units distributed nationwide in the United States and internationally to 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. The affected devices were manufactured between January 2008 and May 2019 across numerous lot codes.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Distribution: 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. Quantity: 219988 units Lot/code info: 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 9
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.