Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis Recalled by Zimmer Biomet, Inc. Due to LDPE bag containing the implant adheres to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.
Affected Products
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
Quantity: 32537
Why Was This Recalled?
LDPE bag containing the implant adheres to the highly polished implant surface.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report