CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product recalled
Musculoskeletal Transplant Foundation is recalling AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), distributed in Minnesota. The recall was initiated on 22 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1066-2024
- FDA event ID
- 93853
- Recalling firm
- Musculoskeletal Transplant Foundation, Edison, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2023
- FDA classified
- 9 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2023 | Recall initiated by company | |
| 9 Feb 2024 | Classified by FDA | +49 days |
| 21 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Product as listed by the FDA
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Where it was distributed
Product was distributed to Minnesota.
Questions about this recall
Why was it recalled?
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Which lots are affected?
Donor Lot 02921115411127. UDI-DI: W4184227010T0473
Where was it sold?
Product was distributed to Minnesota.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93853| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product recalled | Musculoskeletal Transplant Foundation | Other | MN |
More recalls from Musculoskeletal Transplant Foundation
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product recalled | Musculoskeletal Transplant Foundation | Other | MN |
| Device | CLASS II | DBX Demineralized Bone Matrix Putty 10cc-Indicated recalled | Musculoskeletal Transplant Foundation | Device Malfunction | Nationwide |
| Device | CLASS II | AFT Straight Tube (3/4 Filled) - Human Allograph Tissue recalled | Musculoskeletal Transplant Foundation | Device Malfunction | Nationwide |
| Device | CLASS II | QuickGraft¿ Model # 430PST recalled by Musculoskeletal Transplant | Musculoskeletal Transplant Foundation | Other | 5 states |
| Device | CLASS II | AFT Diverted Tube (3/4/Filled), indicated recalled | Musculoskeletal Transplant Foundation | Sterility | Nationwide |
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