Christchurch, New Zealand
Enztec Limited recalls
1 recall recorded since 2018, most recently on 16 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 August 2019
- Terminated
- 2 March 2023
- Reason
- The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
- Distribution
- CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0612-2020
- REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.