Recall Z-1943-2014 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Blue Belt Technologies MN
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
| Date | Jun 27, 2014 (initiated Jun 4, 2014) |
| Status | Terminated |
| 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. |
| 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 | 2 |
| Distribution | US Nationwide Distribution in the states of CA, PA, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123380 | STRIDE UNICONDYLAR KNEE Blue Belt Technologies, Inc., May 31, 2013 |