Medical Devices Recalls

The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

The concentration of bromocresol purple in the recalled lots does not conform to specification.

A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.

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

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

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

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

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.

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.

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.

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.

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

The concentration of bromocresol purple in the recalled lots does not conform to specification.

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.