Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker CMF Customized Implant Kit X-Large Recalled by Stryker Howmedica Osteonics Corp. Due to Stryker received a report from the field that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Howmedica Osteonics Corp. directly.
Affected Products
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.
Quantity: one unit
Why Was This Recalled?
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Where Was This Sold?
This product was distributed to 1 state: PA
About Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report