FDA-Device2016-09-14Class II
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped. Total elbow prosthesis designed for use with bone
Zimmer Biomet, Inc.
Hazard
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
Sold states
Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
Affected count
25 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped. Total elbow prosthesis designed for use with bone cement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2752-2016Don't want to check this manually?
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