Recall Z-2004-2016— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-2004-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-21

Class II · Terminated

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2016-04-21, terminated 2016-10-18. It names 2 FDA 510(k) clearances: K060161, K042125. Product: 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.. Reason: 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..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Terminated: 2016-10-18
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K060161 — AFT ALLOGRAFT FILLER TUBEMusculoskeletal Transplant Foundation·cleared 2006-03-21
K042125 — AFTMusculoskeletal Transplant Foundation·cleared 2005-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.