AFT (Allograft Filler Tube) Straight Tube (1/2 Filled) recall
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Why was AFT (Allograft Filler Tube) Straight Tube (1/2 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?
Donor Lot 02921115411127. UDI-DI: W4184227010T0473
- Product
- AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Quantity
- 89
- Distribution
- Product was distributed to Minnesota.
- Recall date
- February 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)