FDAFDA · Food and drugs·Recall number Z-2131-2014
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
Published August 6, 2014 · Recall initiated: June 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
- Lot
- Part Number 00-2358-014-04; lot 62276042
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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