H3 Hintermann Ankle Replacement System
H3 Hintermann Ankle Replacement System Recall The H3 Hintermann ankle replacement system is being recalled in Australia because registry data shows it has a higher rate of revision surgery (replacement or repair) compared to other similar ankle replacement systems. This recall affects patients who have received this implant across Australia. The TGA has classified this as a Class I recall, indicating a serious concern.
- Reason
- The TGA has concerns about an increased risk of revision as shown in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data when compared to other fixed and mobile bearing systems.
- Classification
- Class I
- Category
- medical device recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2026-02-12
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/d2d07eb8-29cb-4f13-aa5a-d7467a12f792