Reported Feb 3, 2021 · Terminated
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Enztec Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Enztec Limited · 26 Dakota Crescent, Sockburn · Christchurch · N/A
Is this the product you have?
REF 800-05-035ENZTEC FEMORAL IMPACTOR - DJO(01) 09421028110624 (10) 999999To be used only with DJO EMPOWR 3D KNEE
- Lot codes and dates
- Lot number Distribution Date
161471 08-Jun-16161472 08-Jun-16161473 08-Jun-16161474 08-Jun-16161475 08-Jun-16161476 08-Jun-16161477 08-Jun-16161756 29-Jun-16161757 29-Jun-16161758 29-Jun-16161759 29-Jun-16161760 29-Jun-16161761 29-Jun-16161762 29-Jun-16161822 22-Jul-16161823 22-Jul-16161824 22-Jul-16161825 22-Jul-16161826 22-Jul-16161827 22-Jul-16161828 22-Jul-16170760 24-Mar-17170761 24-Mar-17170762 24-Mar-17170763 24-Mar-17170764 24-Mar-17170765 24-Mar-17170766 24-Mar-17170767 24-Mar-17170768 24-Mar-17171989 23-Jun-17
- Lot number Distribution Date
- Amount recalled
- 312 Femoral Impactors
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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