Edison, NJ, United States
Musculoskeletal Transplant Foundation, Inc. recalls
4 recalls recorded since 2018, most recently on 22 December 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 December 2023
- Reason
- Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Distribution
- Product was distributed to Minnesota.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1066-2024, Z-1067-2024
- AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Ongoing Class II Medical devices
- Recall started
- 22 September 2023
- Reason
- Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
- Distribution
- US Nationwide distribution in the states of PA, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0323-2024
- DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
Terminated Class II Medical devices
- Recall started
- 29 March 2021
- Terminated
- 27 April 2023
- Reason
- 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
- Distribution
- US Nationwide distribution in the state of MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1562-2021
- AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Nu
Terminated Class II Medical devices
- Recall started
- 15 August 2019
- Terminated
- 1 July 2020
- Reason
- Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
- Distribution
- NY NC LA TX MO OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2548-2019
- QuickGraft¿ Model # 430PST
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.