Stryker CMF Customized Implant Kit X-Large recallZ-0975-2014 · Stryker Howmedica Osteonics Corp. · initiated Dec 6, 2013
Class II Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
FDA root cause category: Labeling Change Control
What the company is doing
Stryker Orthopaedics sent Urgent Medical Device Recall Notification letters/Product Recall Acknowledgement Forms dated 12/6/2013 to US branch/agency. surgeons, hospital risk managers, and sales representatives.
Recall details
- Recall number
- Z-0975-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 6, 2013
- Posted by the FDA
- Feb 12, 2014
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- one unit
- Product code
- KKY
- FDA submissions
- K103010
- Distribution
- Distributed in PA.
Product description
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Code information (models, lots, serial numbers)
510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Other devices under the same FDA submission
1 device cleared under K103010 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 5444-0-300Howmedica Osteonics Corp. · MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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