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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Percutaneous Pin Adapter

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  Class 2 Device Recall Medtronic Percutaneous Pin Adapter see related information
Date Initiated by Firm December 06, 2018
Create Date December 19, 2019
Recall Status1 Terminated 3 on December 17, 2020
Recall Number Z-0707-2020
Recall Event ID 84045
510(K)Number K131425  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
Code Information Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409. 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Todd Hansell
720-890-3241
Manufacturer Reason
for Recall		 Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
FDA Determined
Cause 2		 Device Design
Action The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly.
Quantity in Commerce 1,297 percutaneous pin adapters
Distribution Distribution was nationwide. There was government/military/foreign distribution.
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 = OLO and Original Applicant = MEDTRONIC NAVIGATION, INC.
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