Zimmer Locking Plate System Recalls Distal Fibular Plates Due to Thread Defect
Zimmer recalls distal fibular plates with defective locking holes that may prevent proper screw fixation during orthopedic surgery, potentially requiring additional intervention.
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: FDA Class II recall for a surgical fixation device with a mechanical defect that may result in loss of fixation and require additional surgery. No reported illnesses or injuries are documented in the source text, placing this at High severity per the rubric criterion for risk-of-harm products without reported adverse outcomes.
Plain-English summary
Zimmer, Inc. is recalling certain lots of its ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plates (Item Number 47-2357-018-06) due to a thread form defect in the locking holes.
The defect may prevent locking screws from properly mating with the plate. Because the screw may not correctly lock but may still appear seated to the surgeon, the defect may not be readily recognizable during implantation. This could result in loss of surgical fixation, requiring further intervention or additional surgery to correct the problem.
The affected plates were distributed worldwide, including throughout the United States and internationally to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. The product is a surgical implant used for temporary internal fixation and stabilization of bone fractures and osteotomies.
Healthcare providers and facilities using these plates should verify lot numbers and item numbers, quarantine affected inventory, and contact Zimmer, Inc. Surgeons should be alert to the possibility of improper fixation in patients who may have received implants from the affected lots.
The recalled product
- Product
- ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
- Manufacturer
- Zimmer, Inc.
- Hazard
- improper-fixation
- mechanical-defect
Distribution
Distributed nationwide across the United States.
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