Recall Z-2210-2015— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-2210-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-27

Class II · Terminated

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2015-05-27, terminated 2015-12-17. It names one FDA 510(k) clearance: K061498. Product: Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.. Reason: Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Terminated: 2015-12-17
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K061498 — ALLOFIX ANCHOR, 5.0 MM ANCHORMusculoskeletal Transplant Foundation·cleared 2006-07-06

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

Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.

Reason for recall

Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.

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