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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Matrix System T1 Matrix Locking Cap

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  Class 2 Device Recall Synthes Matrix System T1 Matrix Locking Cap see related information
Date Initiated by Firm March 11, 2011
Date Posted September 15, 2011
Recall Status1 Terminated 3 on December 18, 2014
Recall Number Z-3207-2011
Recall Event ID 59290
510(K)Number k100952  k092929  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000.

Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Code Information All lots
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.
FDA Determined
Cause 2		 Labeling Change Control
Action The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Consultant.
Distribution Nationwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI.
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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = SYNTHES (USA)
510(K)s with Product Code = NKB and Original Applicant = SYNTHES SPINE
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