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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Spine ZeroP Instruments and Implants

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  Class 2 Device Recall Synthes Spine ZeroP Instruments and Implants see related information
Date Initiated by Firm September 23, 2011
Date Posted October 21, 2011
Recall Status1 Terminated 3 on December 18, 2014
Recall Number Z-0104-2012
Recall Event ID 60004
510(K)Number K072981  K093762  
Product Classification Intervertebral fusion device with bone graft, cervical - Product Code ODP
Product Synthes Spine Zero-P Instruments and Implants.

Zero-profile anterior cervical interbody fusion (ACIF) device.

Code Information N/A - Labeling Correction
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 - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.
FDA Determined
Cause 2
Labeling False and Misleading
Action Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.
Distribution USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
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 = ODP and Original Applicant = SYNTHES SPINE
510(K)s with Product Code = ODP and Original Applicant = SYNTHES SPINE CO.LP
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