Zimmer Biomet recalls limb salvage arthroplasty devices made before January 2014 due to risk of implants sticking to LDPE packaging during use.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Zimmer Biomet is recalling certain limb salvage arthroplasty devices made before January 2014. These devices may adhere to LDPE packaging, which could cause complications during surgery or implantation.
The implants may stick to the LDPE (low-density polyethylene) packaging used in the previous configuration. This could lead to the implant becoming stuck during surgery or implantation, potentially causing complications.
Patients and surgeons who own or use the recalled devices made before January 2014 are affected. Surgeons using these devices for limb salvage procedures are at the highest risk.
Check for device item numbers listed in the recall (e.g., 00585000011, 00585001201) on the packaging. The devices were manufactured before January 2014.
Look for the specific item numbers listed in the recall on the packaging of the device.
Reach out to Zimmer Biomet directly for further guidance on the recall.
The recall states that non-highly polished implants may adhere to LDPE packaging, but the devices are not unsafe for use if they were manufactured after January 2014.
Check the device item numbers listed in the recall (e.g., 00585000011, 00585001201) and verify they were manufactured before January 2014.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0323-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0323-2020 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.
