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Terminated

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

FDA Recall Z-1943-2014 · Posted 2014-06-27

Recalling FirmBlue Belt Technologies MN
Recall StatusTerminated
Product CodeHSX
Date Initiated2014-06-04
Date Terminated2014-08-04
Product Quantity2

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide Distribution in the states of CA, PA, and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123380STRIDE UNICONDYLAR KNEEBlue Belt Technologies, Inc. · 2013-05-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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