Synthes (USA) Products LLC Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The subject product measures 4.0mm in diameter instead of 3.5mm.

Recommended Action

Per FDA guidance

On September 16, 2019, the firm distributed Urgent Medical Device Recall letters to customers, notifying them that the affected screws measure 4.0mm in diameter instead of 3.5mm. Customers should take the following actions: 1. Immediately review your inventory to identify and quarantine the subject product in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section and return to firm even if you have no product on hand. If you have product to be returned: - Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. - Return the Verification Section included with the letter with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 - Send a copy of the completed Verification Section to DePuy Synthes by: Scan/email: RA-DPYCH-flactionint@ITS.JNJ.com - Return any subject product within 30 business days. 3. Forward the notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of the notice visibly posted for awareness until all product subject to this recall (removal) has been returned. While processing your return, please maintain a copy of the notice with the product subject to this recall (removal) and keep a copy for your records. If you have any questions, please call 610-719-5450 (8 am 5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.

Distribution

As reported by FDA

NJ