Enztec recalls femoral impactors used with DJO EMPOWR 3D Knee due to higher risk of arm fracture during surgery, potentially causing delays or revision surgery.
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.
Enztec is recalling femoral impactors that come with DJO EMPOWR 3D Knee systems because they can cause the arm to break during surgery. This may lead to a delay in surgery or require additional procedures if the broken piece isn't removed.
The femoral impactors have a higher than normal risk of the arm breaking during surgery. If the tip fractures and separates from the instrument, it can cause a delay in surgery. If not retrieved, it may lead to an inflammatory response requiring revision surgery.
Surgical teams using Enztec femoral impactors with DJO EMPOWR 3D Knee systems are affected. Patients undergoing knee surgery with these specific instruments are at risk.
Check for the model number REF 800-05-035 on the Enztec femoral impactor. These items were sold with DJO EMPOWR 3D Knee systems between June 2016 and June 2017.
Verify the model number on the Enztec femoral impactor to confirm it matches REF 800-05-035.
Reach out to DJO directly for instructions on handling the recalled item if you have it.
The femoral impactors have a higher than normal risk of the arm breaking during surgery, which can cause delays or require revision surgery if not addressed.
No, but surgical teams should check if they have the recalled model and contact DJO for guidance.
Check the model number and contact DJO for instructions on handling the recalled item.
We’ve drafted a message you can send Enztec to request your refund or repair — edit it as you like.
Subject: Recall Z-0612-2020 — Enztec Enztec Hello, I own a Enztec that is covered by recall Z-0612-2020 from Enztec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
