FDAFDA · Alimentos y medicamentos·N.º oficial Z-2084-2012
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.
Publicado el 1 de agosto de 2012 · Inicio del retiro: 22 de diciembre de 2011
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
Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Howmedica Osteonics Corp.
- Distribuidor
- Worldwide Distribution
- Lote
- Catalog Number 8000-1089. Lot Number(s): RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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