Zimmer Biomet recalls certain hip and knee implants that may have LDPE bag residue after removal, potentially affecting implant surface. Affected models include CR-FLEX OPT FEM C-L through E-R.
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 packaging material left on the implant after removal. This could affect the implant's surface and potentially cause complications during surgery or long-term use.
The LDPE plastic bag used for packaging may stick to the highly polished implant surface, leaving residue. This residue could potentially affect the implant's surface during surgery or long-term use, though the risk is not severe.
Patients who received one of the recalled CR-FLEX OPT FEM hip or knee implants. Those with implants from the listed model numbers are most at risk.
Check if your implant model starts with 'CR-FLEX OPT FEM' and ends with 'C-L', 'C-R', 'D-L', 'D-R', 'E-L', 'E-R', 'F-L', or 'F-R'. The specific model numbers listed in the recall include 00-5956-013-06 through 00-5956-017-06.
Review the model number on your implant to see if it matches the listed numbers in the recall (00-5956-013-06 through 00-5956-017-06).
The recall only applies to specific model numbers. If your implant model is not in the list, it is not affected.
The LDPE bag may leave residue on the implant surface after removal, which could potentially affect the implant's surface during surgery or long-term use.
The recall does not mention a fix or remedy. Affected patients should check with their surgeon about potential next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1047-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1047-2018 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.
