Recall Z-1943-2014— Blue Belt Technologies MN

Name: FDA recall Z-1943-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Class II · Terminated

Class II FDA medical device recall by Blue Belt Technologies MN, initiated 2014-06-04, terminated 2014-08-04. It names one FDA 510(k) clearance: K123380. Product: Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.. Reason: Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral..

Recalling firm: Blue Belt Technologies MN
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Terminated: 2014-08-04
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K123380 — STRIDE UNICONDYLAR KNEEBlue Belt Technologies, Inc.·cleared 2013-05-31

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

Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

Reason for recall

Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.

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