FDA-Device2014-01-08Class II
TIB NAIL
Zimmer, Inc.
Hazard
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Sold states
Worldwide Distribution.
Affected count
42, 065 units total
Manufactured in
345 E Main St, Warsaw, IN, United States
Products
TIB NAIL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief