FDA Device recall Z-2016-2012
Stryker T2 Arthrodesis Nailing System
- FDA Device
- Class II
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class II recall of Stryker T2 Arthrodesis Nailing System by Stryker Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2016-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-01-26 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Code information is listed as Catalogue Number, Description and Lot Number (K Number) and is as follows: Catalog No.…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 Arthrodes |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2016-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.