FDA-Device2014-07-16Class II
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.
Zimmer Manufacturing B.V.
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.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
Affected count
496
Manufactured in
Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2032-2014Don't want to check this manually?
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