FDAFDA · Food and drugs·Recall number Z-2032-2014
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Published July 16, 2014 · Recall initiated: June 12, 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
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Manufacturing B.V.
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
- Lot
- Lot No. 62629432 Lot No. 62628759
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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