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U.S. Department of Health and Human Services

Class 2 Device Recall Serrated Soft Tissue Shields

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  Class 2 Device Recall Serrated Soft Tissue Shields see related information
Date Initiated by Firm July 11, 2014
Date Posted August 01, 2014
Recall Status1 Terminated 3 on August 14, 2014
Recall Number Z-2136-2014
Recall Event ID 68863
Product Classification Guide, surgical, instrument - Product Code FZX
Product Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Code Information Part numbers X079-0096 and X079-0097 with Lot #12320
Recalling Firm/
Manufacturer		 X Spine Systems Inc
452 Alexandersville Rd
Miamisburg OH 45342-3658
For Additional Information Contact Kriss Anderson
937-847-8400
Manufacturer Reason
for Recall		 Revision B of the tissue shields of the device was 7 mm longer than the previous design.
FDA Determined
Cause 2		 Employee error
Action X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410
Quantity in Commerce A total of 5-pieces of each part number distributed
Distribution US Distribution including the states of FL and MO.
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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