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U.S. Department of Health and Human Services

Class 2 Device Recall EXPEDIUM

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  Class 2 Device Recall EXPEDIUM see related information
Date Initiated by Firm April 21, 2015
Date Posted May 26, 2015
Recall Status1 Terminated 3 on October 03, 2018
Recall Number Z-1674-2015
Recall Event ID 71067
510(K)Number K101070  K142460  K111136  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Code Information LOT NUMBER: ARNDC6 & ARN DC7
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Melissa McCaughey
508-977-6947
Manufacturer Reason
for Recall		 Device does not mate as intended.
FDA Determined
Cause 2		 Process design
Action Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.
Quantity in Commerce 183 devices
Distribution US: PA and OUS: SE, BE, IT, PT
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 = NKB and Original Applicant = DEPUY SPINE, INC.
510(K)s with Product Code = NKB and Original Applicant = JOHNSON AND JOHNSON
510(K)s with Product Code = NKB and Original Applicant = MEDOS INTERNATIONAL SARL
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