TEI Biosciences PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm recall — FDA Z-2080-2023
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Complete FDA and NHTSA recall records dated in July 2023.
These records include useful source details for the selected month.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
undeclared peanuts
Undeclared almonds and/or undeclared wheat
Product may be contaminated with Salmonella
May contain trace amounts of undeclared milk
Product may be contaminated with Salmonella
Product may be contaminated with Salmonella
Romaine lettuce may be contaminated with deer feces.
Potential glass quality issue that may result in glass chips in the product
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.