Recall Z-0935-2025

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

FDA-determined cause: Under Investigation by firm

Action taken

On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to surgi@sklarcorp.com. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.