DJO recalls EMPOWR Tibial Knee Punch Handles with part numbers 801-05-040 and 801-05-018 due to potential pin loosening that could leave debris in the joint. Affected units have specific lot numbers.
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
DJO is recalling two specific parts for their EMPOWR Knee system because a small pin might become loose during use, which could leave debris in the knee joint. This is a safety issue for people who have had knee surgery with this device.
The retaining pin in the tibial punch handle could become loose and fall out during use. If not noticed, this might leave debris inside the knee joint, which could cause complications after surgery.
Patients who have received knee surgery using DJO EMPOWR systems with the recalled parts are most at risk. Healthcare providers using these parts for surgical procedures may also be affected.
Check for part numbers 801-05-040 or 801-05-018 in the DJO EMPOWR Tibial Knee Punch Handle. Affected units have specific lot/serial numbers listed in the recall notice.
Look for part numbers 801-05-040 or 801-05-018 in the DJO EMPOWR Tibial Knee Punch Handle.
The recall is because the retaining pin could become loose and fall out during use, potentially leaving debris in the knee joint.
The recall does not specify a remedy, so check with DJO for further instructions if you have the recalled parts.
Yes, affected units have specific lot/serial numbers listed in the recall notice.
We’ve drafted a message you can send DJO to request your refund or repair — edit it as you like.
Subject: Recall Z-0060-2021 — DJO DJO Hello, I own a DJO that is covered by recall Z-0060-2021 from DJO. 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.
