Stryker T2 Arthrodesis Nailing System
Medical device recall Z-2016-2012. Published in FDA’s Enforcement Report on Jul 25, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 25, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 532 units. how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
532 units., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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…
FDA’s list runs to 22,832 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 26, 2012.
- FDA classified it on Jul 16, 2012.
- FDA’s Enforcement Report published it on Jul 25, 2012.
- FDA terminated it on Jul 17, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Howmedica Osteonics Corp., of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 22,832 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.