| Class 2 Device Recall DePuy Synthes | |
Date Initiated by Firm | November 07, 2012 |
Date Posted | January 24, 2013 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number | Z-0705-2013 |
Recall Event ID |
63665 |
510(K)Number | K101993 |
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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Product | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl
Product Code: 1867-15-870
Spinal Implant Component. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
DePuy Spine, Inc. 325 Paramount Dr Raynham MA 02767-5199
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For Additional Information Contact | 508-828-3769 |
Manufacturer Reason for Recall | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
FDA Determined Cause 2 | Component change control |
Action | DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606. |
Quantity in Commerce | 34 units |
Distribution | Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia. |
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 = NKB
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