LINK BIO CORP: Device Recall
Recall #Z-2445-2024 · 06/27/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2445-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LINK BIO CORP
- Status
- Ongoing
- Date Initiated
- 06/27/2024
- Location
- Dover, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
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.
Product Description
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Distribution Pattern
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.