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U.S. Department of Health and Human Services

Class 2 Device Recall NAVIO Soft Tissue Protector

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  Class 2 Device Recall NAVIO Soft Tissue Protector see related information
Date Initiated by Firm February 27, 2020
Create Date April 01, 2020
Recall Status1 Open3, Classified
Recall Number Z-1634-2020
Recall Event ID 85110
510(K)Number K121936  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product NAVIO Soft Tissue Protector, included in instrument kits.

The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.
Code Information Component Product Number: PFSR101092;   a. Instrument Kit Number: PFSR02050, Lot Numbers 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248;   b. Instrument Kit Number: PFSR02051, Lot Numbers 4354, 5514;   c. Instrument Kit Number: PFSR02052, Lot Numbers 4354, 5494, 6248;   d. Instrument Kit Number: PFSR02053, Lot Numbers 6248     
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall		 Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
FDA Determined
Cause 2		 Device Design
Action The firm, Smith & Nephew, notified customers on about 03/03/2020 via "Urgent Medical Device Recall Notice" letter. The customers were Instructed to examine inventory and quarantine affected devices, notify customers if further distributed, and complete and return the Response Form to fieldactions@smith-nephew.com or fax to 1-901-566-7975. Questions and concerns can be directed to EieldActions@smlth-nephew .com. or 901-399-1970.
Quantity in Commerce 348 units
Distribution Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV. International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = BLUE BELT TECHNOLOGIES, INC.
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