FDA Medical Device Recalls (openFDA)
Blue Belt Technologies MN: Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
- Recall number
- Z-1942-2014
- Recalling firm
- Blue Belt Technologies MN
- Product
- Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
- Status
- Terminated
- Initiated
- 2014-06-04
- Posted
- 2014-06-27
- Terminated
- 2014-08-04
- 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
- Lot, serial or model codes
- Lot C785231, Exp 5-2015
- 510(k) numbers
- ["K123380"]
- PMA numbers
- not on file
- Product code
- HSX
- Firm FEI
- 3010266064
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28