FDA Device recall Z-1814-2016
PerFuse Decompression Instrument PN: 800-0541, Lot:100650
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of PerFuse Decompression Instrument PN: 800-0541, Lot:100650 by Biomet, citing the Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1814-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-11 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | CA, GA, MN, OH |
Product
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Reason
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Identifiers
| code_info | PerFuse Decompression Instrument PN: 800-0541, Lot:100650 |
|---|
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-1814-2016%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.