Device Recall Orthopedic implant

  • Model / Serial
    Modular Shoulder Body Assembly, 15mm, Left: Part number: SH-1540L-S ; Work order number/Lot: W51097 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month)  Modular Shoulder Body Assembly, 15mm, Right : Part number: SH-1540R-S ; Work order number/Lot: W51098 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.
  • Product Description
    Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
  • Product Description
    Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
  • Manufacturer