FDAJanuary 11, 2016device
Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as ...
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
UPCs
474815006011
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402412026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402422026-05-20
- FDABrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A2026-05-11
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