Class I - Dangerous
The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.
Class I - Dangerous
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Otto Bock Healthcare GmbH
Class I - Dangerous
A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.
Class I - Dangerous
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Class I - Dangerous
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Class I - Dangerous
The labeling is missing the size/diameter information.
During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue