Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
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, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling the VERSA-FX Femoral Fixation System Compression Lag Screw, an orthopedic implant. The recall involves screws in various lengths (55 mm to 155 mm) and diameters (12.7 mm and 15.8 mm) with item codes starting with 00-1193-005, 00-1193-010, and 00-1193-015.
The recall was initiated because a single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed a leak test. This failure compromised the sterility of the product. A total of 85,794 units are affected by this recall.
The affected products were distributed worldwide, including the United States (nationwide, including Puerto Rico and US Virgin Islands) and numerous international locations such as Israel, Argentina, Brazil, France, Mexico, and Canada. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the removal or replacement of these implants.
The recalled product
- Product
- VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
- 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
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