AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Reported: February 21, 2024 Initiated: December 22, 2023 #Z-1066-2024
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.
Details
- Recalling Firm
- Musculoskeletal Transplant Foundation, Inc.
- Units Affected
- 89
- Distribution
- Product was distributed to Minnesota.
- Location
- Edison, NJ
Frequently Asked Questions
What product was recalled? ▼
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler). Recalled by Musculoskeletal Transplant Foundation, Inc.. Units affected: 89.
Why was this product recalled? ▼
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1066-2024.
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