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 Peak Intraline Anchor 6.5 mm

  • 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 Peak Intraline Anchor 6.5 mmsee related information
Date Initiated by FirmFebruary 07, 2008
Date PostedAugust 06, 2008
Recall Status1 Terminated 3 on December 21, 2010
Recall NumberZ-1535-2008
Recall Event ID 46916
510(K)NumberK071157 
Product Classification Bone Fixation Screw - Product Code HWC
ProductStryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.
Code Information Lot numbers 07276AE2, 07299AE2, 07311AE2
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		Product package may crack and cause loss of sterility.
FDA Determined
Cause 2		Packaging
ActionStryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.
Quantity in Commerce146 units
DistributionProduct was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
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.
510(K) Database510(K)s with Product Code = HWC
-
-