Recall Z-2487-2012 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
| Date | Sep 28, 2012 (initiated Apr 2, 2012) |
| Status | Terminated |
| 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 |
| Quantity | 10, 983 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |