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U.S. Department of Health and Human Services

Class 2 Device Recall T2 Ankle Arthrodesis System Nail and Nut Adapter

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 Class 2 Recall
T2 Ankle Arthrodesis System Nail and Nut Adapter
see related information
Date Posted November 26, 2010
Recall Status1 Terminated on November 22, 2013
Recall Number Z-0481-2011
Recall Event ID 50117
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ
Code Information Catalog Number 1806-3213 and 18063211; Lot codes: K726345 and K679684
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.
FDA Determined
Cause 2
DESIGN: Process Design
Action Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118.
Quantity in Commerce 8 sets
Distribution Nationwide Distribution: To one location in New Jersey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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