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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 89
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
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Musculoskeletal Transplant Foundation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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