Zimmer ZPLP Fibular Plate May Fail to Lock Properly During Surgery
The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further 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 a Class II medical device recall with a defect that poses a risk of compromising surgical fixation and requiring further intervention. However, no illnesses or injuries have been reported in the source text, making this a risk-of-harm scenario with theoretical rather than documented consequences.
Plain-English summary
Zimmer, Inc. is recalling certain ZPLP Distal Lateral Fibular Plates (Right, 8 Holes, 132 MM, Nonsterile) due to a thread form defect in the locking holes that may prevent locking screws from properly engaging with the plate.
When the screw does not properly mate with the plate, the defect may not be readily recognizable by the user during surgery. The screw may fail to lock correctly, resulting in loss of fixation. This can cause delays in surgery or compromise the surgical outcome, potentially requiring further intervention.
The affected device item number is 00-2357-017-08 (GTIN: 00889024055889). Multiple lot numbers are affected. The device 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.
Healthcare providers and surgical facilities should review inventory for the affected lot numbers, quarantine affected units, and contact Zimmer with any questions. Patients who may have received this implant should consult their healthcare provider or surgeon immediately.
The recalled product
- Product
- ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
- Manufacturer
- Zimmer, Inc.
- Hazard
- locking-failure
- loss-of-fixation
- device-defect
Distribution
Distributed nationwide across the United States.
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