Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility was compromised, posing a risk of infection (high-risk hazard), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer, Inc. is recalling the VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile. The recall involves 85,794 units distributed worldwide, including the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East.
The recall was initiated because a single packaging configuration used for the product failed a leak test. This failure compromised the sterility of the product, which is a critical requirement for orthopedic implants.
Healthcare providers and patients should contact Zimmer, Inc. for instructions on how to handle the affected devices. The source text does not specify specific actions for consumers or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 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…
- Manufacturer
- Zimmer, Inc.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
- HighZimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns
FDA (Devices) · 2016-03-23
- ModerateZimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues
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- ModerateZimmer Recalls Versa-FX Orthopedic Implants Due to Packaging Validation Issues
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- ModerateZimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
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