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U.S. Department of Health and Human Services

Class 2 Device Recall Guide and KWires for T2 and Gamma systems

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 Class 2 Device Recall Guide and KWires for T2 and Gamma systemssee related information
Date Initiated by FirmJanuary 21, 2016
Date PostedFebruary 25, 2016
Recall Status1 Terminated 3 on June 08, 2017
Recall NumberZ-0875-2016
Recall Event ID 73156
510(K)NumberK123604 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophil - Product Code MAY
ProductStryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Code Information Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactMr. Eric Petschler
201-831-5000
Manufacturer Reason
for Recall		During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
Quantity in Commerce147,838 units in total
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAY
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