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Terminated

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

FDA Recall Z-0612-2020 · Posted 2020-01-24

Recalling FirmEnztec Limited
Recall StatusTerminated
Product CodeHWA
Date Initiated2019-08-16
Date Terminated2023-03-02
Product Quantity312 Femoral Impactors

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.

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

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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