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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Xia Precision System

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 Class 2 Recall
Stryker Xia Precision System
see related information
Date Posted February 16, 2010
Recall Status1 Terminated on September 06, 2012
Recall Number Z-0789-2010
Recall Event ID 54274
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
Code Information Catalog number: 48237110; all lots
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8150
Manufacturer Reason
for Recall
Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.
Quantity in Commerce 2727 total - all sizes.
Distribution Nationwide distribution.
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.
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