FDA-Device2024-02-21Class II
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Musculoskeletal Transplant Foundation, Inc.
Hazard
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Sold states
Product was distributed to Minnesota.
Affected count
89
Manufactured in
125 May St Ste 300, N/A, Edison, NJ, United States
Products
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1066-2024Don't want to check this manually?
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