FDAFDA · Food and drugs·Recall number Z-2016-2012

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

Published July 25, 2012 · Recall initiated: January 26, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Stryker Howmedica Osteonics Corp.
Distributor: Nationwide.
Lot: Code information is listed as Catalogue Number, Description and Lot Number (K Number) and is as follows: Catalog No. Description Lot No. 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K948548 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K102535 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K141824 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K155506 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K114992 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K395488 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K105496 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K923725 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K252636 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K137348 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K965902 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K695563 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K857453 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K862864 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K739588 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K245215 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K228300 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K219678 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K237017 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K133228 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K128489 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K960393 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K178967 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K923723 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K243246 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K252638 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K224305 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K172103 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K117496 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K261302 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K210496 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K189318 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K161024 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K255675 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K249773 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K206467 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K163054 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K153010 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K133229 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K129741 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K551191 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K579446 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K718554 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K395487 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K241618 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K221660 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K206470 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K133230 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K547010 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K477263 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K971898 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K862865 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K283864 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K395485 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K605002 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K207158 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K149929 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K114002 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K233828 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K869700 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K130896 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K784981 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K551192 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K579447 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K289448 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K177753 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K293136 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K250375 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K182
Risk classification: Class II
Area (FDA): device
Country: United States

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