Zimmer surgical fracture plates may fail to lock properly
Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation 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 a Class II recall with no reported injuries or hospitalizations. However, the thread defect represents a structural failure in a load-bearing orthopedic implant that could result in loss of fixation—a serious clinical consequence requiring intervention. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Zimmer, Inc. is recalling specific lot numbers of the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile (Item Number: 00-2357-017-04). This orthopedic surgical device is used during surgery for temporary internal fixation and stabilization of fractures and osteotomies.
The recalled devices have a thread form defect in the locking holes. This defect may prevent locking screws from properly mating and locking into the plate. Because improper engagement may not be immediately apparent during surgery, there is a risk that the fixation could be lost during the healing process. Loss of fixation may result in delayed surgery or the need for additional surgical intervention.
The affected products were distributed worldwide, including throughout the United States and to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Korea, Singapore, Switzerland, and Taiwan.
Healthcare providers who use this device should check their inventory against the provided lot numbers. If affected devices are identified, surgeons should carefully inspect the screw-to-plate locking mechanism during any surgical procedures where these plates are used. Contact Zimmer, Inc. for instructions on device replacement or return procedures.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
- Manufacturer
- Zimmer, Inc.
- Hazard
- thread-defect
- improper-locking
- fixation-loss
Distribution
Distributed nationwide across the United States.
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