FDAClass IIFebruary 21, 2024

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled) recall

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

Why was AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled) recalled?

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144

Product
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Recalling firm
Musculoskeletal Transplant Foundation, Inc.
Quantity
50
Distribution
Product was distributed to Minnesota.
Recall date
February 21, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls