PerFuse Decompression Instrument PN: 800-0541 — Class II medical device recall Z-1814-2016
Terminated recall by Biomet, Inc., reported 2016-06-01, distributed in CA, GA, MN, OH. The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery gr
| Recall number | Z-1814-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-04-11 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-05-30 |
| Distributed | CA, GA, MN, OH |
| Countries outside the US | NL |
| Quantity | 22 |
| Lot numbers | 100650 |
Product
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Reason for recall
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
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-1814-2016. 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.