FDA Device recall Z-1860-2017
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option…
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option… by Zimmer Biomet, citing endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1860-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-17 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
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
Reason
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Identifiers
| code_info | Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1860-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.