Medical device 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.

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.

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.

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

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

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

Two planers were found to be unusable during sawbones shoulder training.

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.

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.

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.