FDA Recall
Terminated
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Recall: Z-0612-2020
·
Initiated August 16, 2019
Recall
- Recall Number
- Z-0612-2020
- Event Number
- 84217
- Firm
- Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand
- FEI Number
- 3004641308
- Product Code
- HWA
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 16, 2019
- Posted
- January 24, 2020
- Terminated
- March 2, 2023
Description
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.
Action
On August 16, 2019, a Urgent Medical device recall for Product Correction" letter was emailed to affected consignees. In addition to informing the consignees about the recall, the
Distribution
CA
Quantity
312 Femoral Impactors