Recall Z-0612-2020— Enztec Limited
Class II · Terminated
Class II FDA medical device recall by Enztec Limited, initiated 2019-08-16, terminated 2023-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE. 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..
- Recalling firm
- Enztec Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-16
- Terminated
- 2023-03-02
- Firm location
- Christchurch, New Zealand
Product description
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.