AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseo...

FDA Device Recall #Z-1562-2021 — Class II — March 29, 2021

Recall Summary

Recall Number Z-1562-2021
Classification Class II — Moderate risk
Date Initiated March 29, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Musculoskeletal Transplant Foundation, Inc.
Location Edison, NJ
Product Type Devices
Quantity 672 units

Product Description

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

Reason for Recall

3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

Distribution Pattern

US Nationwide distribution in the state of MN.

Lot / Code Information

Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142

Other Recalls from Musculoskeletal Transplant Foundation...

Recall # Classification Product Date
Z-1066-2024 Class II AFT (Allograft Filler Tube) Straight Tube (1/2 ... Dec 22, 2023
Z-1067-2024 Class II AFT (Allograft Filler Tube) Diverted Tube (3/4 ... Dec 22, 2023
Z-0323-2024 Class II DBX Demineralized Bone Matrix Putty 10cc-Indica... Sep 22, 2023
Z-2548-2019 Class II QuickGraft¿ Model # 430PST Aug 15, 2019
Z-2004-2016 Class II Musculoskeletal Transplant Foundation, AFT Dive... Apr 21, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.