Medical Devices Recalls

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Delivery Sets may have tubing that could become detached that could result in patient infection.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.