Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Brand
Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand
Lot Codes / Batch Numbers
Lot number Distribution Date: 161471 08-Jun-16, 161472 08-Jun-16, 161473 08-Jun-16, 161474 08-Jun-16, 161475 08-Jun-16, 161476 08-Jun-16, 161477 08-Jun-16, 161756 29-Jun-16, 161757 29-Jun-16, 161758 29-Jun-16, 161759 29-Jun-16, 161760 29-Jun-16, 161761 29-Jun-16, 161762 29-Jun-16, 161822 22-Jul-16, 161823 22-Jul-16, 161824 22-Jul-16, 161825 22-Jul-16, 161826 22-Jul-16, 161827 22-Jul-16, 161828 22-Jul-16, 170760 24-Mar-17, 170761 24-Mar-17, 170762 24-Mar-17, 170763 24-Mar-17, 170764 24-Mar-17, 170765 24-Mar-17, 170766 24-Mar-17, 170767 24-Mar-17, 170768 24-Mar-17, 171989 23-Jun-17
Products Sold
Lot number Distribution Date: 161471 08-Jun-16, 161472 08-Jun-16, 161473 08-Jun-16, 161474 08-Jun-16, 161475 08-Jun-16, 161476 08-Jun-16, 161477 08-Jun-16, 161756 29-Jun-16, 161757 29-Jun-16, 161758 29-Jun-16, 161759 29-Jun-16, 161760 29-Jun-16, 161761 29-Jun-16, 161762 29-Jun-16, 161822 22-Jul-16, 161823 22-Jul-16, 161824 22-Jul-16, 161825 22-Jul-16, 161826 22-Jul-16, 161827 22-Jul-16, 161828 22-Jul-16, 170760 24-Mar-17, 170761 24-Mar-17, 170762 24-Mar-17, 170763 24-Mar-17, 170764 24-Mar-17, 170765 24-Mar-17, 170766 24-Mar-17, 170767 24-Mar-17, 170768 24-Mar-17, 171989 23-Jun-17 ,
Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand is recalling REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with due to 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 instr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026