FDA-Device2013-03-20Class II
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Biomet, Inc.
Hazard
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
Sold states
Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
Affected count
58
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0925-2013Don't want to check this manually?
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