FDAFebruary 4, 2015device
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
What to do
FDA enforcement status: Terminated
Brands named
zimmer trabecular metal technologyzimmerzimmer trabecular
UPCs
0054900342400549003410
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCCombination Smoke and Carbon Monoxide (CO) Detectors Recalled Due to Risk of Serious Injury or Death from Failure to Alert Consumers to Fire; Sold Exclusively on Amazon.com by Treatlife Technology2026-06-25
- CPSCYamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash; Violate Mandatory Standard for ATVs2026-06-25
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- FDAOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 1100404762026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402422026-05-20
- FDAOff-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 1100402402026-05-20
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