Zimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause 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: FDA Class II medical device recall involving a defect in the critical locking mechanism of an orthopedic implant. The defect creates risk of loss of fixation and potential need for additional surgery, though no illnesses or injuries have been reported.
Plain-English summary
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to a thread defect in the locking holes that may prevent locking screws from properly engaging with the plate. The affected product is used in orthopedic surgery for internal fixation and stabilization of bone fractures and osteotomies.
When locking screws fail to properly mate with the plate, the defect may not be immediately apparent to the surgeon, as the screw may appear to be locked while not actually securing the implant. This could result in delayed surgery or loss of fixation, potentially requiring additional surgical intervention.
The recall affects implants with UDI codes (01)00889024088610(17)290730(10)64381072 and (01)00889024088610(17)300208(10)64661553, corresponding to lot numbers 64381072 and 64661553. Products have been distributed worldwide, including throughout the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.
If you received this product, contact your healthcare provider or Zimmer, Inc. for guidance on whether your specific product is affected and appropriate next steps.
The recalled product
- Product
- ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
- Manufacturer
- Zimmer, Inc.
- Hazard
- locking-failure
- loss-of-fixation
- surgical-reoperation-risk
Distribution
Distributed nationwide across the United States.
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