CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue recalled
Musculoskeletal Transplant Foundation is recalling AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 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-1562-2021
- FDA event ID
- 87677
- Recalling firm
- Musculoskeletal Transplant Foundation, Edison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2021
- FDA classified
- 12 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 29 Mar 2021 | Recall initiated by company | |
| 12 May 2021 | Classified by FDA | +44 days |
| 19 May 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 Number: 227007
Where it was distributed
US Nationwide distribution in the state of MN.
Questions about this recall
Why was it recalled?
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Which lots are affected?
Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142
Where was it sold?
US Nationwide distribution in the state of MN.
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.
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 | AFT (Allograft Filler Tube) Straight Tube (1/2 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 | 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 |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |