Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-2487-2012

Recalling firm

Stryker Howmedica Osteonics Corp.

Product

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.

Status

Terminated

Initiated

2012-04-02

Posted

2012-09-28

Terminated

2013-06-13

Reason

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.

Root cause

Device Design

Action

Stryker Orthopaedics sent a Urgent Product Field Action - Product Inspection Branch Acknowledgement Form on April 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All inspections must be completed immediately as per the provided Product Correction Bulletin. Please document the results of your inspection on the Tracking Log, indicating conforming devices as "Not Affected" and non-conforming devices as "To be returned." If the devices listed on your tracking log have previously been returned or are otherwise not on hand, indicate the appropriate disposition following our usual process. Please assist us in meeting our regulatory obligation by faxing back the attached Product Acknowledgment Form and Tracking Log within 10 business days to 855-251-3635. Any further questions please call 201-831-5523.

Quantity

10, 983 units

Distribution

Nationwide distribution

Lot, serial or model codes

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.

510(k) numbers

["K013106","K022549","K040734"]

PMA numbers

not on file

Product code

LZO

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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