HU-FRIEDY
Received May 1, 2026 · Event occurred Apr 2, 2026
Report 1416605-2026-00009 · MDR key 25056582
Device
Generic name
Forceps, Tooth Extractor, Surgical
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
F151XASCatalog number
F151XAS
Lot number
1023, 0124, 0424
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
DEVICE WAS RETURNED TO MANUFACTURER. MEASUREMENT OF A SAMPLING OF THE SERRATION DEPTHS SHOWED 0.009, 0.011 AND 0.010 INCH DEPTHS ON THE RETURNED SAMPLES. THERE IS NO ISO SPECIFIC REQUIREMENTS FOR SERRATION DEPTH. AS SUCH, THE DEPTHS OF THE SERRATIONS WERE NOT DEEMED DEEP AND WITHIN EXPECTED RESULTS. SINCE THESE ARE THE ONLY RETURNS FOR THIS PRODUCT CODE FOR THE PAST 12 MONTHS, NO FURTHER ACTIONS WERE DEEMED NECESSARY.
Description of Event or Problem
THE CUSTOMER ADVISED THAT THE SERRATIONS ARE TOO DEEP AND ARE CAUSING TEETH TO CRACK.