| Class 2 Device Recall XIA 3 Iliac Screwdriver, 3PCS | |
Date Initiated by Firm | December 27, 2012 |
Date Posted | February 28, 2013 |
Recall Status1 |
Terminated 3 on September 30, 2015 |
Recall Number | Z-0893-2013 |
Recall Event ID |
64313 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | Stryker XIA 3 Iliac Screwdriver, 3-PCS.
The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument. |
Code Information |
Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852. |
Recalling Firm/ Manufacturer |
Stryker Spine 2 Pearl Ct Allendale NJ 07401-1611
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For Additional Information Contact | Daniel Roberts 201-760-8298 |
Manufacturer Reason for Recall | Surgeons have experienced unthreading of the screwdrivers outer shafts during use. |
FDA Determined Cause 2 | Device Design |
Action | Stryker Spine sent a "Urgent Medical Device Removal" letter dated January 14 2013, via FedEx overnight to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to examine your inventory and hospital inventory locations to identify your product. Please fax a copy of the Customer Response form to (855) 632-9049 to Regulatory Compliance. For further questions please call (201) 760-8298. |
Quantity in Commerce | 46 units US |
Distribution | Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI. |
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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