Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product 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 is classified as FDA Class II. The hazard involves compromised sterility of an orthopedic implant, which poses a risk of infection (a high-risk pathogen exposure scenario) without reported illnesses or fatalities in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling the VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, including standard and short low profiles in various holes, lengths, and angles. The recall involves 85,794 units in total. The product is an orthopedic implant used for femoral fixation.
The recall was initiated because a single packaging configuration used for the system failed the leak test. This failure compromised the sterility of the product. The agency classification for this recall is Class II.
The affected units were distributed worldwide, including the US Nationwide (including Puerto Rico and US Virgin Islands) and numerous international locations such as Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, China, Korea, Canada, Australia, Germany, UK, and others. Consumers and healthcare providers should check their inventory for item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, and 00-1193-150, as well as the specific lot codes listed in the official recall notice.
The recalled product
- Product
- VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140…
- 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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