Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 280 mm, Item Number: 814511280 recall — FDA Z-3122-2018
The set screw is not able to advance or reverse from the original position in the nail.
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The set screw is not able to advance or reverse from the original position in the nail.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The product may be contaminated with Listeria monocytogenes.
Product contains undeclared allergens, egg, crustacean, and pork.
Product contains undeclared allergens egg and crustacean.
Potential for cleaning chemical introduced into product due to process deviation while cleaning pasteurizer.
During FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the allergen statement
During FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the allergen statement
The firm was notified by a customer that mold was in the product.
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183,…
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
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