FDA Device recall Z-1858-2017
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory 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-1858-2017 |
| 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 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
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Identifiers
| code_info | Item 163005 Lot 309030 |
|---|
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-1858-2017%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.