Zimmer Biomet recalls CR-FLEX GSF PCT SZ knee and hip implants due to LDPE packaging residue that may remain on implants after removal. This could affect patients with osteoarthritis, joint fractures, or revision surgeries.
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 certain CR-FLEX GSF PCT SZ knee and hip implants because the LDPE plastic packaging may leave residue on the implants after removal. This could potentially cause issues with the implant's performance or fit.
The LDPE (low-density polyethylene) plastic packaging used for these implants may adhere to the highly polished implant surfaces. When the implant is removed from the bag, small amounts of plastic residue could remain on the implant, potentially affecting its fit or function.
Patients who received these specific Zimmer Biomet hip or knee implants for osteoarthritis, joint fractures, or revision surgeries are likely affected. The risk is minimal as the residue is unlikely to cause serious harm.
Check for the specific model numbers listed in the recall notice (e.g., 00-5750-013-01, 00-5750-014-01). These implants are for patients with osteoarthritis, joint fractures, or revision surgeries and are designed for cemented use only.
Review the model numbers on your implant packaging or documentation to see if they match the recalled list (e.g., 00-5750-013-01, 00-5750-014-01).
The LDPE plastic packaging may leave residue on the highly polished implant surfaces after removal, which could affect the implant's fit or function.
If your implant model is on the recall list, you should check with Zimmer Biomet for further instructions. The recall does not require immediate action but may need evaluation.
The risk is low as the residue is unlikely to cause serious harm. Zimmer Biomet states this is a minor issue that may affect implant fit but not safety.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1058-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1058-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
