Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 289–300 of 1,121 recalls
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Impactor handle may be missing cross-pin
Impactor handle may be missing cross-pin
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Behind-the-ear sound processer packaging label is different then included product.
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Potential for rubber fragment detachment during use.
Potential for rubber fragment detachment during use.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
There is the potential for the length of the trocar shaft to be too long.
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.