Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF 800-05-035 Recalled by Enztec Limited Due to The femoral impactors have a higher than normal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Enztec Limited directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: CA
About Enztec Limited
Enztec Limited has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report