Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1860-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

Product Classification:

Class II

Date Initiated: February 17, 2017

Date Posted: April 26, 2017

Recall Number: Z-1860-2017

Event ID: 76507

Reason for Recall:

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Status: Terminated

Product Quantity: 28,253 in total

Code Information:

Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130 712810 712830 712850 712860 Item 11-105911 577890 Item 11-105912 577920 Item 11-105913 577930 Item 11-105933 577950 Item 11-165208 779480 797810 Item 11-165216 905190 Item 11-165220 905230 Item 11-165222 808510 905270 920560 Item 11-165224 905130 Item 11-165226 758530 758550 797970 920600 Item 11-165228 879860 Item 11-165232 716050 732560 732580 920670 Item 11-165236 896290 Item 11-165240 779430 Item 12-105994 272230 Item CP162598 354160 Item EP-105833 371770 Item EP-105882 604860 Item EP-105894 371780 667310 Item EP-105914 371640 443510 443520 667250 667260 Item EP-105916 455050 577290 Item EP-105917 577300 Item EP-105918 577250 Item EP-105923 455070 577320 577340 728050 728080 728150 728180 Item EP-105925 577380 Item EP-105926 577390 Item EP-105933 455080 577360 Item EP-105934 604870 Item EP-105996 577420 Item EP-107926 811990 Item EP-108223 275040 Item EP-108322 371730 Item EP-108323 371740 667290 667300 Item EP-108424 272270 455100 Item EP-108425 455110 Item EP-108524 455120 Item EP-108525 240900 Item EP-176238 602380 Item EP-200144 455130 455150 728200 728220 Item EP-200146 390550 577450 577460 577480 Item EP-200148 511810 511820 511830 511840 511880 728230 728240 Item EP-200150 455180 455190 511890 511900 511910 728250 728270 Item EP-200152 455200 728300 728320 728340 Item EP-200154 455210 Item EP-200156 577490 577500 Item EP-200158 577510 577520 ItemEP-200160 455220 Item XL-105833 542210 542220 542230 542240 Item XL-105834 542250 Item XL-105835 614420 Item XL-105884 604960 Item XL-105885 588450 Item XL-105903 502330 502340 Item XL-105905 588490 Item XL-105914 502370 502380 Item XL-105923 290100 502390 502410 779270 Item XL-105924 309510 502430 502440 779340 Item XL-105925 502450 Item XL-105933 309520 502460 605000 779590 Item XL-105934 290110 502490 Item XL-105994 309530 Item XL-108222 290120 Item XL-108223 605040 Item XL-200144 605050 Item XL-200146 502590 644000 Item XL-200148 290130 502600 502610 Item XL-200150 502620 502630 Item XL-200152 502640 Item XL-200154 290140 Item XL-200158 502650 Item XL-200160 644030 Item XL-222846 290150 Item XL-223248 290160

Distribution Pattern:

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

Voluntary or Mandated:

Voluntary: Firm initiated