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U.S. Department of Health and Human Services

Class 2 Device Recall Reamers Orthopedic manual surgical instrument

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  Class 2 Device Recall Reamers Orthopedic manual surgical instrument see related information
Date Initiated by Firm February 25, 2015
Date Posted April 21, 2015
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-1480-2015
Recall Event ID 70710
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Code Information Part #: PI-0507, Lot #s:1308811A, 1457704A; Part #: PI-0508, Lot #s: 1308812A, 1457705A; Part #: PI-0509, Lot #s: 1038813A, 1457706A; Part #: PI-0510, Lot #s: 1308814A, 1457707A; Part #: PI-0511, Lot #s: 1308815A, 1457708A; Part #: PI-0512, Lot #s: 1308816A, 1457709A; Part #: PI-0513, Lot #s: 1308817A, 1457710A; Part #: PI-0514, Lot #s: 1308818A, 1457711A; Part #: PI-0507-S, Lot #: 2130005; Part #: PI-0508-S, Lot #: 2130006; Part #: PI-0509-S, Lot #: 2130007; Part #: PI-0510-S, Lot #: 2130008; Part #: PI-0511-S, Lot #: 2130009; Part #: PI-0512-S, Lot #: 2130010; Part #: PI-0513-S, Lot #:2130011; Part #: PI-0514-S, Lot #: 2130012
Recalling Firm/
Manufacturer		 Captiva Spine, Inc
967 Alternate A1A
Suite1
Jupiter FL 33477
For Additional Information Contact Tamala J. Wampler
513-593-4944
Manufacturer Reason
for Recall		 It is possible for the titanium color-coded ring to detach from the Reamers.
FDA Determined
Cause 2		 Device Design
Action On 02/26/2015 the firm sent a Voluntary Correction Notification to its consignees via FedEx. Within that notification the firm asks to please check with your product representative and Central Supply Departments to determine if you have any of the products listed on the notificaiton. If any product is located please call 877-772-5571 from 8:30am (Eastern Time) to receive instructions as to how to remove the color-coded ring OR please follow the enclosed steps for the correction in their entirety. They contain information about returning the removed rings. Enclosed is Form 30.4 Product Tracking and Verification Form. You must complete and return this form even if you do not have any rings to remove and return. Please contact your Captiva Spine customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the correction.
Quantity in Commerce 233 devices
Distribution GA, IN, FL, UT, AZ, CA, and NY
Total Product Life Cycle TPLC 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.
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