FDADecember 7, 2016device
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone aro...
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.
- FDAOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.2025-08-26
- 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
- FDAIMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: IL...2025-07-30
- 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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