FDAFDA · Alimentos y medicamentos·N.º oficial Z-1526-2020
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.
Publicado el 25 de marzo de 2020 · Inicio del retiro: 3 de mayo de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- XTANT MEDICAL INC
- Distribuidor
- US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees.
- Lote
- Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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