Stryker Recalls Incorrect Patient-Specific Customized Implant Kit
Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a delivery error (incorrect patient-specific kit) without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary actions where harm has not been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling one unit of the Stryker CMF Customized Implant Kit X-Large (Catalog # 5444-0-400, Lot Code K08702VR21FEB). The recall was initiated after the company received a field report indicating that an incorrect patient-specific implant kit was delivered to a hospital.
The affected product is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. The recall is limited to the specific unit distributed in Pennsylvania. No illnesses or injuries have been reported in connection with this event.
Hospitals and healthcare facilities that may have received this specific lot should contact Stryker Howmedica Osteonics for instructions on how to return the product. Patients who have already had the implant placed should contact their healthcare provider for guidance.
The recalled product
- 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 cr
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Distribution
Distributed in 1 state:
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