Musculoskeletal Transplant Foundation recalled over sterility concerns

Recall date

April 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Musculoskeletal Transplant Foundation, Inc. recalls Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created os…

Recall number

Z-2004-2016

FDA classification

Class II

Brand / firm

Musculoskeletal Transplant Foundation, Inc.

Sold / distributed

nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.