FDA Device recall Z-0975-2014
Stryker CMF Customized Implant Kit X-Large
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of Stryker CMF Customized Implant Kit X-Large by Stryker Howmedica Osteonics, citing stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0975-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-06 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | PA |
Product
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.
Reason
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Identifiers
| code_info | 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0975-2014%22
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