Class I - Dangerous
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Class I - Dangerous
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Class I - Dangerous
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Class I - Dangerous
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
Mueller Sports Medicine
Class I - Dangerous
Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
Class I - Dangerous
There may be dimensional manufacturing error that represents a potential safety risk to patients.
Class I - Dangerous
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Incorrect expiration date
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured