FDAFDA · Alimentos y medicamentos·N.º oficial Z-1092-2014
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.
Publicado el 5 de marzo de 2014 · Inicio del retiro: 10 de enero de 2014
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
This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- Distribution USA in the state of Illinois.
- Lote
- lot 62267250
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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