The Recall Desk
ModerateFDA (Devices)·Z-1562-2021·Announced 2021-05-19

Musculoskeletal Transplant Foundation Recalls AFT Straight Tubes Due to Filling Error

Musculoskeletal Transplant Foundation is recalling AFT Straight Tubes that were filled only halfway instead of three-quarters, which may cause surgery delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing error (underfilling) that may cause a delay of surgery, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary recall.

Plain-English summary

Musculoskeletal Transplant Foundation, Inc. is recalling 672 units of AFT Straight Tube (3/4 Filled) - Human Allograft Tissue, Item Number 227007. The product is used for the treatment of surgically-created osseous defects or osseous defects created from traumatic injury in the extremities, pelvis, and spine.

The recall was initiated because the tubes were filled only 1/2 way instead of the specified 3/4 way. This manufacturing error may cause a delay of surgery.

The affected units were distributed nationwide in the state of Minnesota. The specific lot numbers involved are 03818070421114, 00319018541145, 00319022171149, 00419019631149, 09819009071105, and 09819036171142. Healthcare providers and patients should check their inventory and contact the recalling firm for instructions on how to return the product.

The recalled product

Product
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Affected units
672

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: