REF 800-05-035 — Class II medical device recall Z-0612-2020
Terminated recall by Enztec Limited, reported 2021-02-03, distributed in CA. The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm
| Recall number | Z-0612-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Enztec Limited, Christchurch, New Zealand |
| Recall initiated | 2019-08-16 |
| Classified | 2019-12-06 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2023-03-02 |
| Distributed | CA |
| Quantity | 312 femoral |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 09421028110624 |
| Model numbers | 800-05-035 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0612-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.