Product Wiki · Recalls · U.S. FDA — Device Enforcement

Musculoskeletal Transplant Foundation, AFT Diverted Tube… — recall Z-2004-2016

U.S. FDA — Device Enforcement · United States · 2016-04-21 · Class II

As described by U.S. FDA — Device Enforcement: Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2004-2016
Date of alert
2016-04-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Musculoskeletal Transplant Foundation, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
nationwide
Barcode (EAN/GTIN)
04314046801122
Reported risk: AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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