Aesculap recalls knee implant components (model nos. NR068K-Z) due to potential LDPE particles in packaging. Affected products may have low-risk contamination but require verification.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Aesculap is recalling certain knee implant components that may have low-density polyethylene (LDPE) particles on their surface after opening the inner packaging. This could pose a minor risk during surgery if particles enter the implant site, but the hazard is not severe enough to cause serious injury in normal use.
The recall states that low-density polyethylene (LDPE) particles may be present on the surface of the implant after opening the inner packaging. If these particles enter the surgical site during implantation, they could potentially cause minor tissue irritation or complications, but the hazard is not severe enough to cause serious injury in normal use.
Patients who received knee implants with model numbers NR068K, NR068Z, NR070K, NR070Z, NR071K, NR071Z, NR072K, NR072Z, NR073K, NR073Z, NR074K, NR074Z, NR075K, NR075Z, NR076K, NR076Z, NR077K, NR077Z, NR078K, or NR078Z from the manufacturer. Surgeons and medical facilities using these implants are most at risk.
Check for model numbers NR068K, NR068Z, NR070K, NR070Z, NR071K, NR071Z, NR072K, NR072Z, NR073K, NR073Z, NR074K, NR074Z, NR075K, NR075Z, NR076K, NR076Z, NR077K, or NR077Z on the implant packaging. Products with old packaging configuration (before Lot 52533610) are affected.
Verify the model number and packaging configuration to confirm if the product is affected.
The recall states that LDPE particles may be present but does not indicate they cause serious injury in normal use. Affected products are considered low-risk.
Check the model number and packaging configuration. If affected, contact Aesculap for further instructions.
The recall does not specify a deadline for action.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1482-2020 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1482-2020 from Aesculap. 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.
