various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight… — Class II medical device recall Z-1858-2017
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-1858-2017 |
|---|---|
| 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 |
| Lot numbers | 309030 |
| Model numbers | 163005 |
Product
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Reason for recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1858-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.