Zimmer Biomet recalls certain Natural-Knee Flex System femoral components (models N-K FLX GSM POR FEM SZ 2-5) for potential LDPE bag residue on implants after removal from packaging.
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 that may have LDPE bag residue left on the implant after removal from packaging. This could affect the implant's performance or safety during surgery.
The LDPE (low-density polyethylene) packaging bag may adhere to the highly polished surface of the implant, leaving residue on the implant after it is removed from the bag. This could potentially affect the implant's performance or safety during surgery, but the risk is considered low.
Patients who received these specific knee implant components during surgery for knee damage repair are likely affected. The risk is minimal as the residue is not expected to cause harm during normal use.
Check for the product model numbers listed in the recall: N-K FLX GSM POR FEM SZ 2 RT, N-K FLX GSM POR FEM SZ 3 LT, N-K FLX GSM POR FEM SZ 4 LT, N-K FLX GSM POR FEM SZ 4 RT, N-K FLX GSM POR FEM SZ 5 LT, N-K FLX GSM POR FEM SZ 5 RT. These components were sold with specific serial numbers.
Identify if your knee implant component matches the recalled models: N-K FLX GSM POR FEM SZ 2 RT, N-K FLX GSM POR FEM SZ 3 LT, N-K FLX GSM POR FEM SZ 4 LT, N-K FLX GSM POR FEM SZ 4 RT, N-K FLX GSM POR FEM SZ 5 LT, N-K FLX GSM POR FEM SZ 5 RT.
The LDPE bag packaging may adhere to the highly polished surface of the implant, leaving residue on the implant after it is removed from the bag.
The recall does not specify a remedy, so no action is required if the implants are functioning properly.
Check if your implant model matches the recalled models listed in the recall notice: N-K FLX GSM POR FEM SZ 2 RT, N-K FLX GSM POR FEM SZ 3 LT, N-K FLX GSM POR FEM SZ 4 LT, N-K FLX GSM POR FEM SZ 4 RT, N-K FLX GSM POR FEM SZ 5 LT, N-K FLX GSM POR FEM SZ 5 RT.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1061-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1061-2018 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.
