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U.S. Department of Health and Human Services

Class 2 Device Recall Orthofix Pedicle Screw Spinal System

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 Class 2 Device Recall Orthofix Pedicle Screw Spinal Systemsee related information
Date Initiated by FirmOctober 22, 2010
Date PostedMarch 08, 2011
Recall Status1 Terminated 3 on April 25, 2011
Recall NumberZ-1608-2011
Recall Event ID 57211
510(K)NumberK081684 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.
Code Information Part #68-0111, Lot #16518-LC18.
FEI Number 2183449
Recalling Firm/
Manufacturer		 Orthofix Inc
3451 Plano Parkway
Lewisville TX 75056-9453
Manufacturer Reason
for Recall		There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.
FDA Determined
Cause 2		Other
ActionThe firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery. If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: DarlaChew@Orthofix.com.
Quantity in Commerce166 Units
DistributionNationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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