Stryker CMF Customized Implant Kit X-Large — Class II medical device recall Z-0975-2014
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-02-19. Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant K
| Recall number | Z-0975-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-12-06 |
| Classified | 2014-02-12 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2015-05-06 |
| Lot numbers | K08702VR21FEB |
| Model numbers | 5444-0-400 |
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 for recall
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0975-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.