Zimmer Fibular Plate Recall: Defective Locking Hole Threading
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone 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 an FDA Class II medical device recall involving a surgical implant with threading defects that could result in loss of bone fixation or surgical delays. No actual injuries, hospitalizations, or deaths have been reported. The hazard represents a risk of harm where injury has not yet been documented, meeting the criteria for High (Score 3).
Plain-English summary
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate (Item Number 00-2357-018-06), a surgical implant designed for temporary internal fixation and stabilization of bone fractures and osteotomies. The plates have a defect in the threading of the locking holes that prevents locking screws from properly mating with the plate.
When a screw does not properly mate with the plate, it may fail to lock correctly. The defect may not be immediately apparent to the surgeon during the procedure. According to the manufacturer, this can result in surgical delays or loss of bone fixation, both of which may require additional surgical intervention.
The recalled plates have 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. Healthcare providers who have received these products should discontinue use and contact Zimmer, Inc. for guidance on device discontinuation and alternatives.
The recalled product
- Product
- ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
- Manufacturer
- Zimmer, Inc.
- Hazard
- threading-defect
- fixation-loss
- improper-locking
Distribution
Distributed nationwide across the United States.
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