PlainRecalls
FDA Devices Moderate Class II Ongoing

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

Reported: July 31, 2024 Initiated: June 27, 2024 #Z-2445-2024

Product Description

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

Reason for Recall

The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

Details

Recalling Firm
LINK BIO CORP
Units Affected
8 units
Distribution
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Location
Dover, NJ

Frequently Asked Questions

What product was recalled?
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00. Recalled by LINK BIO CORP. Units affected: 8 units.
Why was this product recalled?
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2024. Severity: Moderate. Recall number: Z-2445-2024.