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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker T2 Alpha Delta Strike Plate IMN Instruments

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  Class 2 Device Recall Stryker T2 Alpha Delta Strike Plate IMN Instruments see related information
Date Initiated by Firm December 05, 2019
Create Date January 07, 2020
Recall Status1 Terminated 3 on October 09, 2020
Recall Number Z-0780-2020
Recall Event ID 84458
Product Classification Plate, fixation, bone - Product Code HRS
Product Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device
Catalog Number: 2351-0050
Code Information All lots UDI: (01)07613327350210
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Loriann Russo
201-8315272
Manufacturer Reason
for Recall		 Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker issued Urgent Medical Device Recall Letter (PFA# 2219868) to US consignees on 5-Dec-2019 , letter states reason for recall, health risk and action to take: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply. An OUS customer letter was also issued at the country level.
Quantity in Commerce 433 (289 units U.S. / 144 units OUS)
Distribution Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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