Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Stanmore Implants Worldwide
Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Zeus-P Lumbar Interbody Device
Amendia
Class I - Dangerous
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Optimus Fixed Awl
Amendia
Class I - Dangerous
Complaints that the tip of the awl broke after impaction during surgery.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.