Musculoskeletal Transplant Foundation, Inc. recalls AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
- Recall date
- December 22, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1067-2024
- FDA classification
- Class II
- Brand / firm
- Musculoskeletal Transplant Foundation, Inc.
- Sold / distributed
- Product was distributed to Minnesota.
Why it was recalled
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
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