Musculoskeletal Transplant Foundation Recalls AFT Diverted Tubes Due to Unsealed Pouch
Musculoskeletal Transplant Foundation is recalling 114 AFT Diverted Tubes because an unsealed Tyvek pouch could introduce contamination into the sterile field.
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 2/5 (Moderate).
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, but the source text does not report any hospitalizations or significant injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Musculoskeletal Transplant Foundation, Inc. is recalling 114 units of AFT Diverted Tubes (3/4/Filled) due to a customer complaint regarding a unit with an unsealed Tyvek pouch. The product is indicated for the treatment of surgically-created or traumatic osseous defects in the extremities, pelvis, and spine.
The recall was initiated because the non-sterile foil pouch associated with the unsealed Tyvek pouch may introduce contamination into the sterile field during use. The affected units are identified by the serial number 04314046801122 and were distributed nationwide.
Healthcare providers and facilities should stop using the affected AFT Diverted Tubes and contact Musculoskeletal Transplant Foundation, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- Affected units
- 114
Distribution
Distributed nationwide across the United States.
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