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Recall Observatory FDA recall evidence

Device product

REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

Z-0612-2020

August 16, 2019

Class II

Product summary

Firm
Enztec Limited
Event
Event 84217
Status
Terminated
Classification
Class II
Quantity
312 Femoral Impactors
Official record key
device-enforcement:Z-0612-2020

Official wording

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.

Code information: 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 ,

Distribution pattern: CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.