FDADecember 7, 2016device
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
What to do
FDA enforcement status: Terminated
Brands named
stanmore implants worldwidestanmorestanmore implants
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.2025-08-26
- FDAOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.2025-08-26
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- FDAThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as veri...2025-05-01
- FDABrand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusio...2024-12-20
- CPSCHomewerks Worldwide Recalls Allen + Roth Lighted Bathroom Mirrors Due to Injury and Laceration Hazards; Sold Exclusively at Lowe's2024-10-10
- CPSCMJKSARE High Chairs Recalled Due to Entrapment and Fall Hazards; Violation of Federal Regulation for High Chairs; Imported by Worldwide Windows; Sold Exclusively on Amazon.com2024-09-12
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