| Class 2 Device Recall Stryker Titanium Intraline Anchor | |
Date Initiated by Firm | August 20, 2009 |
Date Posted | December 14, 2010 |
Recall Status1 |
Terminated 3 on December 14, 2010 |
Recall Number | Z-0618-2011 |
Recall Event ID |
53182 |
510(K)Number | K071157 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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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 CA 95138-1400
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For Additional Information Contact | 408-754-2124 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HWC
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