Device product

AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

Z-1066-2024

December 22, 2023

Class II

Product summary

Firm: Musculoskeletal Transplant Foundation, Inc.
Event: Event 93853
Status: Ongoing
Classification: Class II
Quantity: 89
Official record key: device-enforcement:Z-1066-2024

Official wording

Reason: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

Code information: Donor Lot 02921115411127. UDI-DI: W4184227010T0473

Distribution pattern: Product was distributed to Minnesota.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.