Z-0223-2020Class II

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

Name: Z-0223-2020 Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Creator: Synthes (USA) Products LLC
Published: 2019-09-16
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2019-09-16 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery on 2019-09-16. FDA classified it as Class II and gives the reason as "The subject product measures 4.0mm in diameter instead of 3.5mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0223-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Posted: 2019-10-28
Terminated: 2020-04-24
Recalling firm: Synthes (USA) Products LLC
Product: Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Product code: NKG Posterior Cervical Screw System
Reason for recall: The subject product measures 4.0mm in diameter instead of 3.5mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] - 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.
Quantity in commerce: 6
Distribution: Distributed to NJ.
Product codes and lots: 10L2702

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0223-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-28

Product code NKG

K142838Class IISynapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC / cleared 2015-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)