Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate…
Medical device recall Z-2487-2012. Published in FDA’s Enforcement Report on Oct 10, 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 Oct 10, 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
- 10, 983 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 Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
10, 983 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm…
Every code shown here, 1,281 characters
Catalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm std cone trial 6278-1-031 Mod Rev 31 mm std cone trial 6278-1-119 Mod Rev 19 mm + 10 mm cone trial 6278-1-121 Mod Rev 21mm + 10 mm cone trial 6278-1-123 Mod Rev 23mm + 10 mm cone trial 6278-1 -125 Mod Rev 25 mm + 10 mm cone trial 6278-1-127 Mod Rev 27mm + 10 mm cone trial 6278-1-129 Mod Rev 29mm + 10mm cone trial 6278-1-131 Mod Rev 31mm + 10 mm cone trial 6278 -1-219 Mod Rev 19mm + 20 mm cone trial 6278-1-221 Mod Rev 21mm +20 mm cone trial 6278-1-223 Mod Rev 23mm + 20 mm cone trial 6278-1-225 Mod Rev 25mm + 20 mm cone trial 6278-1-227 Mod Rev 27mm + 20 mm cone trial 6278-1-229 Mod Rev 29mm + 20 mm cone trial 6278-1-231 Mod Rev 31mm + 20 mm cone trial 6278-1-319 Mod Rev 19mm + 30 mm cone trial 6278-1-321 Mod Rev 21mm +30 mm cone trial 6278-1-323 Mod Rev 23mm + 30 mm cone trial 6278-1-325 Mod Rev 25mm + 30 mm cone trial 6278-1-327 Mod Rev 27mm + 30 mm cone trial 6278-1-329 Mod rev 29mm +30 mm cone trial 6278-1-331 Mod Rev 31mm + 30 mm cone trial 1 single unit to each non-sterile package Numerous lots numbers please see attachment.
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 distribution
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 Apr 2, 2012.
- FDA classified it on Sep 28, 2012.
- FDA’s Enforcement Report published it on Oct 10, 2012.
- FDA terminated it on Jun 13, 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.”
- 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.