Affixus Antegrade Femoral Nails recall — FDA Z-0968-2026
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…
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not…
A certain component of affected devices was not delivered within specification and contained impurities.
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…
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability…
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to…
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
Browse recent months with enough recall history for useful comparison.