Zimmer Distal Lateral Fibular Plate Locking Screw Defect
Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.
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 FDA Class II recall involves a mechanical defect that presents a risk of serious harm (loss of bone fixation and need for additional surgery), but no injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Zimmer, Inc. is recalling certain Periarticular Locking Plate (ZPLP) Distal Lateral Fibular Plates (Item Number 47-2357-017-10) due to a thread form issue in the locking holes. This defect may prevent locking screws from properly mating with and locking to the plate.
The improperly mated screw may not be readily recognizable by the user during surgery, as the screw may not correctly lock. This can result in loss of fixation of the bone plate, potentially causing surgical delays or requiring additional intervention to correct the problem.
The affected product was distributed worldwide, including to the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. The recalled lot is identified by lot number 66060712 with UDI (01)00889024088528(17)330527(10)66060712.
Healthcare providers and patients who have received this implant should contact their healthcare provider or Zimmer, Inc. for guidance on whether the implant requires evaluation or replacement.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-10
- Manufacturer
- Zimmer, Inc.
- Hazard
- mechanical-defect
- loss-of-fixation
- surgical-complication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00889024088528(17)330527(10)66060712 Lot Numbers: 66060712
Distribution
Distributed nationwide across the United States.
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