FDAAugust 16, 2016device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
zimmer biometzimmer
UPCs
32810502701
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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