FDA Device recall Z-1863-2017
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement 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-1863-2017 |
| 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 Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Reason
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Identifiers
| code_info | Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150 |
|---|
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-1863-2017%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.