Device Recall Signature

  • Model / Serial
    Lot 094929
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution: MO only.
  • Product Description
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE || SIGNATURE || M PKA GDE/MDL SET SML-MP || DD.....R-FEB55RKA-T JA-A01 05551 || PKA POST CUT SML-PKA MICROPLASTY || CUSTOM-MADE DEVICE || non-sterile || The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot #154970
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    One consignee, Indiana.
  • Product Description
    Signature TKA GDE/MDL Set 04-05 || Patient-specific surgical guide and instrument set.
  • Manufacturer
  • Model / Serial
    UDI: 09348215001926. Lot:78560.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the country of Australia.
  • Product Description
    Signature Ceramic Femoral Head. Model Number: 111-152-621. || The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). || The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within || the Logical Acetabular Cups. || Product Usage: || Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
  • Manufacturer