Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
FDA device recall Z-1942-2014 · posted 2014-06-27 · Terminated
Recall details
- Recalling firm
- Blue Belt Technologies MN
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 2
- Distribution
- US Nationwide Distribution in the states of CA, PA, and TX
- Date initiated
- 2014-06-04
- Date posted
- 2014-06-27
- Date terminated
- 2014-08-04
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRIDE UNICONDYLAR KNEE (K123380) | Blue Belt Technologies, Inc. | 2013-05-31 |