Zimmer Periarticular Locking Plates Recalled for Potential Loss of Surgical Fixation
Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery 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: This is an FDA Class II medical device recall with no reported injuries or illnesses. However, the thread form defect in a surgical implant creates significant risk of loss of fixation and potential need for revision surgery, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. has recalled certain lots of the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, a surgical device used for temporary internal fixation and stabilization of osteotomies and fractures.
The recall was initiated due to a thread form defect in the locking holes of the plate. This defect may prevent locking screws from properly mating with the plate. Because the improper seating may not be readily recognizable during surgery, the screw may not correctly lock, potentially resulting in loss of fixation or delay in completing the surgery.
Loss of fixation or surgical delays may require further intervention to restore proper surgical fixation. The affected units were distributed worldwide, including throughout the United States and internationally.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
- Manufacturer
- Zimmer, Inc.
- Hazard
- loss-of-fixation
- thread-defect
- device-malfunction
Distribution
Distributed nationwide across the United States.
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