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U.S. Department of Health and Human Services

Class 2 Device Recall Wedge HS Suture Anchor II, 6.5 mm with Needles

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  Class 2 Device Recall Wedge HS Suture Anchor II, 6.5 mm with Needles see related information
Date Initiated by Firm February 07, 2008
Date Posted August 06, 2008
Recall Status1 Terminated 3 on December 21, 2010
Recall Number Z-1538-2008
Recall Event ID 46916
510(K)Number K983557  
Product Classification Soft Tissue Fixation Fastener - Product Code MBI
Product Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145
Intended for use in securing soft tissue to bone in certain procedures in specific areas.
Code Information Lot Numbers 07299AE2
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
Manufacturer Reason
for Recall
Product package may crack and cause loss of sterility.
FDA Determined
Cause 2
Action Stryker 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 Commerce 53 units
Distribution Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MBI and Original Applicant = Stryker Endoscopy