Zimmer Periarticular Locking Plate threading defect may compromise surgical fixation
Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.
What this means for you
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: This FDA Class II medical device presents a risk of surgical failure (loss of fixation) requiring additional intervention, but no injuries or adverse events have been reported. It meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, 8 Holes, 132 MM (Item Number 47-2357-017-08) due to a thread form defect in the locking holes. The defect can prevent locking screws from properly mating with the plate.
The improper mating may not be immediately recognizable during surgery, as the screw may appear locked when it is not. This defect could result in loss of surgical fixation and require additional intervention.
The affected plates were distributed worldwide, including to the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. The recall includes three specific lot numbers: 64811254, 64811255, and 65834885.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
- Manufacturer
- Zimmer, Inc.
- Hazard
- loss-of-fixation
- thread-form-defect
Distribution
Distributed nationwide across the United States.
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