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U.S. Department of Health and Human Services

Class 2 Device Recall Guided Handle Kit

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  Class 2 Device Recall Guided Handle Kit see related information
Date Initiated by Firm June 26, 2017
Create Date September 11, 2017
Recall Status1 Terminated 3 on June 16, 2021
Recall Number Z-3115-2017
Recall Event ID 77554
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883.

The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
Code Information Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Customer Care
888-649-6425
Manufacturer Reason
for Recall		 The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
FDA Determined
Cause 2		 Process control
Action Implant Direct sent an Safety Alert /Advisory Notice letter dated June 26, 2017. Instructions included to review and remove inventory for return to Implant Direct, complete and return the acknowledgement and recall return form, and contact customers and notify the of the recall if product was further distributed. For further questions, please call (888) 649-6425.
Quantity in Commerce 84 units
Distribution Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
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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