stryker corporation

It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.

Due to nonconforming products being inadvertently distributed.

Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.