Recall Z-1066-2024— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-1066-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Class II · Ongoing

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2023-12-22. It names one FDA 510(k) clearance: K042125. Product: AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler). Reason: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-22
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K042125 — AFTMusculoskeletal Transplant Foundation·cleared 2005-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.