FDAJanuary 11, 2016device
Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 787101561 VERSYS CEM/REV/CALCAR 1...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
What to do
FDA enforcement status: Terminated
Brands named
zimmer manufacturing b vzimmerzimmer manufacturing
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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