Zimmer Biomet recalls Vanguard Complete Knee Systems with specific model numbers due to potential mix-up of 12mm and 14mm tibial bearings, which could lead to extended surgery time.
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
Zimmer Biomet is recalling certain Vanguard Complete Knee Systems because some packages might contain the wrong size tibial bearings (12mm labeled as 14mm or vice versa). This could cause surgeons to spend extra time finding the correct implant during knee replacement surgery.
The recall involves two specific lots of tibial bearings that may have been mixed up. A 14mm bearing could be in a box labeled for 12mm, and vice versa. This mix-up might require surgeons to find the correct size implant during surgery, leading to longer procedure times.
Patients who received the recalled Vanguard Complete Knee Systems with model numbers EP-183664 or EP-183642 are affected. Surgeons performing knee replacements using these specific models are most at risk of extended surgery time.
Check for model numbers EP-183664 or EP-183642 on the Vanguard Complete Knee System packaging. The affected lots are 198810 and 210320.
Look for model numbers EP-183664 or EP-183642 on the packaging to determine if the product is affected.
Two lots of tibial bearings were commingled, meaning a 14mm bearing might be packaged in a box labeled for 12mm and vice versa, which could lead to extended surgery time.
Check the model numbers on the packaging. If it's EP-183664 or EP-183642, contact Zimmer Biomet for guidance.
The recall is for potential extended surgery time, not direct injury. Serious injury is not mentioned in the recall.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2289-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2289-2018 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.
