various polyethylene implants Hips Active Articulation ArComXL… — Class II medical device recall Z-1860-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-04-26, distributed nationwide. Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
| Recall number | Z-1860-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-02-17 |
| Classified | 2017-04-18 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2018-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CH, CL, CN, CR, EC, GB, IN, IT, JP, KR, MX, MY, PA, SG, TH |
| Quantity | 28,253 in |
| Reason classes | sterility |
| Model numbers | 11-105900, 11-105901, 11-105902, 11-105911, 11-105912, 11-105913, 11-105933, 11-165208, 11-165216, 11-165220, 11-165222, 11-165224, 11-165226, 11-165228, 11-165232, 11-165236, 11-165240, 12-105994, 240900, 272230, 272270, 275040, 290100, 290110, 290120 and 202 more |
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 for recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.