Z-1943-2014Class II

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

Name: Z-1943-2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis
Creator: Blue Belt Technologies MN
Published: 2014-06-04
License: https://open.fda.gov/license/

Blue Belt Technologies MN / initiated 2014-06-04 / Terminated / root cause: labeling and UDI

FDA source

Blue Belt Technologies MN began a recall of Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis on 2014-06-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1943-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Posted: 2014-06-27
Terminated: 2014-08-04
Recalling firm: Blue Belt Technologies MN
Product: Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm initiated recall on 6/4/2014 by Blue Belt Technologies representatives hand delivering an Urgent Medeical Device Recall letter. The letter was addressed to the attention of Safety Officer/Regulatory Compliance Officer. The letter described the issue of the labeling mix-up, asked for devices to be quarantined, and stated that a Blue Belt Technologies Clinical Specialist will be contacting the consignee or return and replacement. A Receipt Acknowledgement form was asked to be returned by fax or mail.
Quantity in commerce: 2
Distribution: US Nationwide Distribution in the states of CA, PA, and TX
Product codes and lots: Lot C785241, Exp 4-2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1943-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27

Product code HSX

K123380Class IIStride Unicondylar KneeBlue Belt Technologies, Inc. / cleared 2013-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)