Zimmer Biomet recalls certain CR-FLEX PCT FEM hip and knee implants that may have LDPE bag residue after removal, potentially affecting implant surface quality.
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 hip and knee implants that may have residue from the LDPE packaging material on the implant surface after removal. This could affect the implant's performance and long-term function.
The LDPE packaging material may stick to the highly polished implant surface after removal, leaving residue. This residue could potentially affect the implant's surface quality and long-term performance.
Patients who received the recalled CR-FLEX PCT FEM implants (models listed in the recall) are affected. Those with implants that were packaged in LDPE bags are most at risk.
Check if your implant model matches the list of CR-FLEX PCT FEM models provided in the recall (e.g., CR-FLEX PCT FEM B-R, C-L, etc.). The packaging used for these implants may have been LDPE bags.
Identify your implant model by checking the product code on the implant package or documentation.
The recall does not specify a remedy, so no action is required unless you have the specific models listed. Contact Zimmer Biomet directly for further guidance.
The recall states that LDPE bag residue may affect implant surface quality, but it does not indicate a risk of serious injury or harm.
Check if your implant model matches the list of CR-FLEX PCT FEM models provided in the recall (e.g., CR-FLEX PCT FEM B-R, C-L, etc.).
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1050-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1050-2018 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.
