FDA recall Z-0612-2020

Product

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

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.

Distribution

CA

Key facts

Status

Terminated

Initiation date

2019-08-16

Report date

2021-02-03

Termination date

2023-03-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Christchurch, New Zealand

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2020