Z-0612-2020Class II

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

Name: Z-0612-2020 REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO...
Creator: Enztec Limited
Published: 2019-08-16
License: https://open.fda.gov/license/

Enztec Limited / initiated 2019-08-16 / Terminated

FDA source

Enztec Limited began a recall of REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE on 2019-08-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0612-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-16
Posted: 2020-01-24
Terminated: 2023-03-02
Recalling firm: Enztec Limited
Product: REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Product code: HWA Impactor
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.
FDA root cause: Unknown/Undetermined by firm
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
Quantity in commerce: 312 Femoral Impactors
Distribution: CA
Product codes and lots: 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 ,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0612-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0612-2020	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2019-12-06

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)