Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Straight Static Inserter Assembly MFG Part of the AVS navigator Peek Spacer Systemsee related information
Date Initiated by FirmDecember 18, 2013
Date PostedFebruary 25, 2014
Recall Status1 Terminated 3 on August 25, 2014
Recall NumberZ-1086-2014
Recall Event ID 67388
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductSpecialty 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
FEI Number 3004024955
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactMr. 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		Device Design
ActionStryker 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 Commerce21 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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.
-
-