Class II — Enztec Limited
| Recalling firm | ENZTEC LIMITED |
|---|---|
| Registered facility | ENZTEC LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE |
| Quantity | 312 Femoral Impactors |
| Distribution | CA |
| Initiated | 2019-08-16 |
| Classified | 2019-12-06 |
| Terminated | 2023-03-02 |
| Recall number | Z-0612-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Enztec Limited (Z-0612-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84217/
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