Hand Files
- Recalling firm
- Law and Accounting Professional Trustees Limited
- Product
- Hand Files. [Device]. Model: Endodontic Hand Files (K-Flex, Triple-Flex, K-Files, Hedstrom); Endodontic Hand Files ( Reamers). Affected: Multiple lot number; Multiple lot numbers. Also covers: Reamers
- Reason
- It has recently come to the manufacturer attention that the IFU has an error in the cleaning section step # 1 for the ultrasonic cycle time. The IFU incorrectly stated: Clean the hand pluggers in an ultrasonic device for five (5) minutes using a neutral-pH enzymatic ultrasonic detergent (Enzol Enzymatic Detergent, or equivalent) is recommended. However, the IFU should state: Clean the hand files in an ultrasonic device for ten (10) minutes using a neutral-pH enzymatic ultrasonic detergent (Enzol Enzymatic Detergent, or equivalent) is recommended. To this date, no adverse events have been...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-16
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/62da27a6-8f3c-4f8c-a21e-1f8a431bf604