ðĨ Medical Devices âĒ 4,540 recalls
3M Company - Health Care Business
Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Otto Bock Healthcare GmbH
Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Inadequate biocompatibility testing.
Inadequate biocompatibility testing.
Potential for separation of the proximal handle from the shaft.
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Inadequate biocompatibility testing.
Inadequate biocompatibility testing.
The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
Images contained within radiographic transparency ART 1036 are undersized.
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264