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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWQ 510(K)s with Product Code = KWQ
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