ZPLP Distal Lateral Fibular Plates: locking screws may not secure
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical 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 risk-of-harm orthopedic device where a manufacturing defect could result in loss of surgical fixation and need for further intervention. No injuries or illnesses are reported in the source. FDA Class II classification without reported harm justifies a High severity rating.
Plain-English summary
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates (Item Number: 00-2357-017-06), which are used for temporary internal fixation and stabilization of bone fractures and osteotomies. The plates have a thread form issue in the locking holes that may prevent locking screws from properly mating with the plate.
When a locking screw does not properly mate with the plate, the screw may not correctly lock in place. This defect may not be immediately recognizable to the user during surgery, creating a risk that fixation will be inadequate or lost, potentially requiring further surgical intervention.
The affected plates were distributed worldwide, including throughout the United States and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. Multiple lot numbers are affected.
Healthcare providers and patients who have received or may have implanted affected plates should contact Zimmer, Inc. or the FDA for guidance on identification of affected devices and appropriate clinical management.
The recalled product
- Product
- ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
- Manufacturer
- Zimmer, Inc.
- Hazard
- threading-defect
- loss-of-fixation
Distribution
Distributed nationwide across the United States.
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