PerFuse Decompression Instrument PN: 800-0541 recall
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Why was PerFuse Decompression Instrument PN: 800-0541 recalled?
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PerFuse Decompression Instrument PN: 800-0541, Lot:100650
- Product
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- Recalling firm
- Biomet, Inc.
- Quantity
- 22
- Distribution
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)