Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, 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 harm (infection) even though specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Zimmer, Inc. is recalling the Free Lock Femoral Hip Fixation System Compression Tube/Plate. The recall involves various lengths, hole counts, and degree angles, with item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, and 00-1181-150. A total of 85,794 units are affected by this action.
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. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including the United States (nationwide, including Puerto Rico and US Virgin Islands) and numerous international locations such as Canada, Australia, and various countries in Europe, Asia, and the Middle East. Healthcare providers and facilities should check their inventory for the specific item codes listed in the recall notice and stop using the affected units.
The recalled product
- Product
- Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER…
- 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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