Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Stryker see related information
Date Initiated by Firm July 24, 2014
Date Posted October 14, 2014
Recall Status1 Terminated 3 on June 08, 2017
Recall Number Z-0065-2015
Recall Event ID 69065
510(K)Number K131365  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13.

Product Usage:
The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
Code Information Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Paul Jahnke
201-831-5826
Manufacturer Reason
for Recall		 Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Stryker Orthopaedics sent an "Urgent Medical Device Removal" letter dated July 23, 2014 and Business Reply Form to their Branches/Agencies via e-mail on July 23, 2014 and their Hospital Risk Management was sent Notification Letters and Product Accountability Forms via FedEx (with return receipt) by July 24, 2014. The recall letter informed the customer of the problem. The customer was asked to return all affected products available to Stryker Osteosynthesis, c/o Paul Jahnke, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, REF: PFA #2014-101 or Contact Stryker's customer service and refer to PFA #2014-101 for returning the product to Stryker. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to: 1 (855) 251-3635 or email a copy to Aminah Crawford, Recall Coordinator at aminah.crawford@stryker.com.
Quantity in Commerce 484 units
Distribution US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
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 = HSB and Original Applicant = Stryker Trauma AG
-
-