Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2014 - (Recall #: Z-0975-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 6, 2013

Date Posted: February 19, 2014

Recall Number: Z-0975-2014

Event ID: 67384

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.

Status: Terminated

Product Quantity: one unit

Code Information:

510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB

Distribution Pattern:

Distributed in PA.

Voluntary or Mandated:

Voluntary: Firm initiated