Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE Recalled by Zimmer, Inc. Due to Single packaging configuration used for the VERSA-FX-II Femoral...
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, Inc. directly.
Affected Products
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
Quantity: 85, 794 units in total
Why Was This Recalled?
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report