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U.S. Department of Health and Human Services

Class 2 Device Recall Synapse System

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 Class 2 Device Recall Synapse Systemsee related information
Date Initiated by FirmSeptember 16, 2019
Create DateOctober 28, 2019
Recall Status1 Terminated 3 on April 24, 2020
Recall NumberZ-0223-2020
Recall Event ID 83948
510(K)NumberK142838 
Product Classification Posterior cervical screw system - Product Code NKG
ProductSynapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Code Information 10L2702
FEI Number 3008812560
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactCustomer Service
610-719-5450
Manufacturer Reason
for Recall		The subject product measures 4.0mm in diameter instead of 3.5mm.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce6
DistributionDistributed to NJ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NKG
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