Medical Devices Recalls

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.

Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.

One lot of humeral stem implants do not include the humeral bushing components.

Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure