Date Initiated by Firm |
December 18, 2013 |
Date Posted |
February 25, 2014 |
Recall Status1 |
Terminated 3 on August 25, 2014 |
Recall Number |
Z-1086-2014 |
Recall Event ID |
67388 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product |
Specialty Straight Static Inserter Assembly
Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges. |
Code Information |
D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242 |
Recalling Firm/ Manufacturer |
Stryker Spine 2 Pearl Ct Allendale NJ 07401-1611
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For Additional Information Contact |
Mr. Daniel Roberts 201-760-8298
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Manufacturer Reason for Recall |
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
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FDA Determined Cause 2 |
Device Design |
Action |
Stryker sent Urgent Medical Device Removal Notification letter and to their customers via email on 12/18/2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, return affected product using enclosed pre-paid mailing label, complete Customer Response Form and fax to Regulatory Compliance at 855-632-9049 or mail it to Spine-RegulatoryActions@Stryker.com. For questions call 201-760-8287, 201-760-8298 or 201-760-8041. |
Quantity in Commerce |
21 units |
Distribution |
US Nationwide Distribution |
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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