FDA-Device2014-09-03Class II
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Zimmer, Inc.
Hazard
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Sold states
Worldwide Distribution.
Affected count
972,125 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2014Don't want to check this manually?
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