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Terminated

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.

FDA Recall Z-2004-2016 · Posted 2016-06-16

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusTerminated
Product CodeMBP
Date Initiated2016-04-21
Date Terminated2016-10-18
Product Quantity114 units

Reason for Recall

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.

Firm Action

Musculoskeletal Transplant Foundation (MTF) sent an Voluntary Field Action Notification Letter dated April 21, 2016, and via telephone to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified of the situation with the product and provided instructions on how to handle the product. Questions can be directed to Customer Service Customer at 1-800-433-6576.

Root Cause

Packaging process control

Distribution Pattern

nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060161AFT ALLOGRAFT FILLER TUBEMusculoskeletal Transplant Foundation · 2006-03-21K042125AFTMusculoskeletal Transplant Foundation · 2005-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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