# FDA recall Z-0612-2020

> **Enztec Limited** · Class II · device recall initiated 2019-08-16.

## 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

- **Recall number:** Z-0612-2020
- **Recalling firm:** Enztec Limited
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0612-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0612-2020. Source: US FDA. Licensed CC0.

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