Zimmer Locking Plate System recalled due to thread mating defect
Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.
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 is a Class II medical device recall with potential risk of harm. The source explicitly indicates no injuries have been reported; the hazard is a thread mating issue that could delay surgery or cause loss of fixation. This qualifies as a 'risk-of-harm product where injury has not yet been reported' per the severity rubric.
Plain-English summary
Zimmer, Inc. is recalling the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile, used for temporary internal fixation and stabilization of osteotomies and fractures. The recall is due to a thread form issue in the locking holes that may prevent the locking screws from properly mating with the plate.
When the locking screw fails to properly mate, it may not correctly lock in place. This defect may not be readily recognizable by the user, making it difficult to identify during surgery. Improper fixation could result in surgical delay or loss of fixation, requiring further surgical intervention.
The affected product carries Lot Numbers 64475611 and 64475612 and has been distributed worldwide, including throughout the United States and to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-16
- Manufacturer
- Zimmer, Inc.
- Hazard
- thread-defect
- locking-failure
- loss-of-fixation
Distribution
Distributed nationwide across the United States.
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