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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Titanium Intraline Anchor

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 Class 2 Recall
Stryker Titanium Intraline Anchor
see related information
Date Posted December 14, 2010
Recall Status1 Terminated on December 14, 2010
Recall Number Z-0618-2011
Recall Event ID 53182
Premarket Notification
510(K) Number
K071157 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
Code Information Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
Manufacturer Reason
for Recall
Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records. Stryker can be contacted at 408 754-2000 about this recall.
Quantity in Commerce 447 units
Distribution Nationwide Distribution: to one distributor in NJ.
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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = Stryker Endoscopy
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