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U.S. Department of Health and Human Services

Class 2 Device Recall IBD Disc Space Distractor

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 Class 2 Recall
IBD Disc Space Distractor
see related information
Date Posted January 12, 2011
Recall Status1 Terminated on November 14, 2012
Recall Number Z-0895-2011
Recall Event ID 57462
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.
Code Information Catalog number # IS2346AVS; All lots
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall
Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court Allendale, New Jersey 07401 For questions regarding this recall call 201-760-8206.
Quantity in Commerce 21 units
Distribution Nationwide Distribution including AZ, FL, MA, NY, PA, and TX
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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