Affixus Antegrade Femoral Nails recall — FDA Z-0970-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a…
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which…
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of particulate matter: potential presence of metal particulates in the product.
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Undeclared allergen - milk
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Potential Salmonella contamination
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
partially hydrogenated oils (PHOs) in foods exported to the US
partially hydrogenated oils (PHOs) in foods exported to the US
Undeclared allergens (Peanut) due to mispackaging
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.
Potential contamination with Salmonella
Product may be contaminated with Listeria monocytogenes.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
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