Z-0975-2014Class II

Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica...

Name: Z-0975-2014 Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-12-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-12-06 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2013-12-06. FDA classified it as Class II and gives the reason as "Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0975-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-06
Posted: 2014-02-12
Terminated: 2015-05-06
Recalling firm: Howmedica Osteonics Corp
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.
Product code: KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: one unit
Distribution: Distributed in PA.
Product codes and lots: 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0975-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0975-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-12

Product code KKY

K103010Class IIStryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics / cleared 2010-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)