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U.S. Department of Health and Human Services

Class 2 Device Recall Cervical Spine Locking Plate (CSLP) System

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  Class 2 Device Recall Cervical Spine Locking Plate (CSLP) System see related information
Date Initiated by Firm January 06, 2016
Date Posted April 20, 2016
Recall Status1 Terminated 3 on January 31, 2017
Recall Number Z-1524-2016
Recall Event ID 73549
510(K)Number K000536  K971883  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
Code Information Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact David Carvin
610-719-5443
Manufacturer Reason
for Recall
DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).
FDA Determined
Cause 2
Packaging process control
Action DePuy Synthesis sent an Urgent Notice Medical Device Recall letter dated January 6, 2016 to customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to complete and return the attached Verification Section (page 3 of the letter). For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 30 units of Lot # 9666776 and 11 units of Lot # 9671879
Distribution Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KWQ and Original Applicant = SYNTHES (USA)
510(K)s with Product Code = KWQ and Original Applicant = SYNTHES SPINE
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