ðĨ Medical Devices âĒ 4,540 recalls
MicroPort Orthopedics
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.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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.
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Bard Peripheral Vascular
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
MEDLINE INDUSTRIES, LP - Northfield
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.
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
MEDLINE INDUSTRIES, LP - Northfield
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
MEDLINE INDUSTRIES, LP - Northfield
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Bolton Medical
The product may be shorter than packaging indicates
Bolton Medical
The product may be shorter than packaging indicates
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.