Recalls / —

—#176790

Product

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

FDA product code

NKG — Posterior Cervical Screw System

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K142838

Affected lot / code info

10L2702

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Synthes (USA) Products LLC

Address

1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern

Distributed to NJ.

Timeline

Recall initiated

2019-09-16

Terminated

2020-04-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #176790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.