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U.S. Department of Health and Human Services

Class 2 Device Recall Straight Static Inserter Assembly MFG Part of the AVS navigator Peek Spacer System

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 Class 2 Recall
Straight Static Inserter Assembly MFG Part of the AVS navigator Peek Spacer System
see related information
Date Posted February 25, 2014
Recall Status1 Open
Recall Number Z-1086-2014
Recall Event ID 67388
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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, New Jersey 07401-1611
For Additional Information Contact Mr. Daniel Roberts
201-760-8298
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.
FDA Determined
Cause 2
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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