Recall Z-2445-2024— LINK BIO CORP
Class II · Ongoing
Class II FDA medical device recall by LINK BIO CORP, initiated 2024-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00. Reason: 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..
- Recalling firm
- LINK BIO CORP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-27
- Firm location
- Dover, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.