Bone Filler Tubes Recalled Due to Manufacturing Process Defect
The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device—a high-risk surgical implant. While no injuries or hospitalizations have been reported, the manufacturing defect creates a clear risk of harm (surgical complications from extrusion failure) where injury has not yet been realized.
Plain-English summary
The FDA is recalling 89 units of the AFT (Allograft Filler Tube) Straight Tube, Product Code 227010, manufactured by Musculoskeletal Transplant Foundation, Inc. This is a bone void filler used in surgical procedures.
The recall was initiated because the filling process qualification failed to demonstrate adequate process capability. This defect may result in extrudability issues, meaning the filler material may not extrude properly during surgical implantation, potentially extending surgery time and complicating the procedure.
The affected product was distributed to Minnesota. Patients or healthcare providers who have received or are considering this product should contact their healthcare provider or the manufacturer for guidance. The recalled units are identified by Donor Lot 02921115411127 and UDI-DI W4184227010T0473.
The recalled product
- Product
- AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- manufacturing-defect
- extrusion-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Donor Lot 02921115411127. UDI-DI: W4184227010T0473
Distribution
Distribution scope not specified by the agency.
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