Zimmer Biomet recalls certain GENDER SOLUTIONS Natural Knee Flex System femoral components for potential LDPE bag residue on implants after removal. This may cause minor surface issues but does not pose serious injury risks.
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Zimmer Biomet is recalling specific knee implant components due to LDPE packaging residue that may remain on the implant after removal. This residue could cause minor surface issues but does not pose serious injury risks to users.
The LDPE plastic bag used for packaging may stick to the highly polished implant surface, leaving residue after the implant is removed from the bag. This residue could cause minor surface issues but does not lead to serious injury or health problems.
Patients who received the recalled GENDER SOLUTIONS Natural Knee Flex System femoral components (specific model numbers listed) during surgery for knee damage. Those with the exact model numbers mentioned in the recall are most at risk.
Check if your knee implant has the specific model numbers listed in the recall (e.g., 00-5414-013-02 61768287, 00-5414-013-02 61871391, etc.). The product is used for knee surgery in patients with noninflammatory or inflammatory joint diseases.
Identify if your implant has the specific model numbers listed in the recall (e.g., 00-5414-013-02 61768287, 00-5414-013-02 61871391, etc.).
The LDPE packaging may leave residue on the implant after removal, which could cause minor surface issues but does not pose serious injury risks.
No action is required if the implant is not one of the recalled model numbers. Check the model numbers listed in the recall to see if your implant is affected.
The recall lists specific model numbers like 00-5414-013-02 61768287, 00-5414-013-02 61871391, and others. Check your implant's packaging or documentation for these numbers.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1060-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1060-2018 from Zimmer Biomet. 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.