Inka - Uterine Curette
- Recalling firm
- Obex Medical Ltd
- Product
- INKA - Uterine curette. [Device]. Model: SIMS UTERINE CURETTE SZ1 RIGID SHARP 26.5. Affected: Product code - INK-16378.01
- Reason
- Intrauterine surgical procedures, particularly those involving mechanical trauma to the endometrium, may be associated with the formation of intrauterine adhesions. In clinically significant cases, these adhesions may result in Asherman Syndrome., The risk may be influenced by the clinical circumstances, including the underlying condition, the extent of endometrial trauma, repeated intrauterine procedures and other patient- or procedure-related factors., The Instructions for Use (IFU) of the affected devices has been updated to include information regarding intrauterine adhesions and...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d8b31988-581c-40f4-8a0c-50918af16fe0