Bone void filler recalled due to manufacturing process control issue
Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.
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: FDA Class II medical device with a manufacturing process control deficiency that directly affects product performance. The hazard is theoretical—no injuries or adverse events reported—but involves a surgical implant where inadequate process qualification could impact surgical outcomes, meeting the rubric criterion for risk-of-harm products without reported harm.
Plain-English summary
Musculoskeletal Transplant Foundation, Inc. is recalling AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005, a bone void filler used in surgical procedures. This recall affects 50 units that were distributed to Minnesota.
The manufacturer discovered that the filling process qualification did not demonstrate adequate process capability. This means the manufacturing process was not properly validated to ensure the product would function as intended during surgical use.
Possible consequences include extended surgery time due to extrudability issues—the product may not properly extrude from the tube during surgical application. Healthcare providers should be aware of this potential issue when using recalled units with UDI-DI W4184227005T0473 and donor lots 00322029241137 and 00322039641144.
If you have received this recalled product, contact Musculoskeletal Transplant Foundation, Inc. for handling instructions. No adverse events related to this issue have been reported to date.
The recalled product
- Product
- AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- process-defect
- extrudability-issue
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)
- UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Distribution
Distribution scope not specified by the agency.
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