Events

Recall of KNEE UNDERSLEEVE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OSSUR HF.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    81137
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A field correction dur to some products that contained rubber latex material were not labelled with the appropriate caution statement.

Device

KNEE UNDERSLEEVE
  • Model / Serial
    Model Catalog: B-250150202 (Lot serial: N/a); Model Catalog: B-250150201 (Lot serial: N/a); Model Catalog: B-250150206 (Lot serial: n/a); Model Catalog: B-250150205 (Lot serial: n/a); Model Catalog: B-250150204 (Lot serial: n/a); Model Catalog: B-250150203 (Lot serial: n/a); Model Catalog: NL-P3 (Lot serial: Before MX151001); Model Catalog: NL-P2 (Lot serial: Before MX151001); Model Catalog: NL-P1 (Lot serial: Before MX151001); Model Catalog: NL-500E (Lot serial: Before MX151001); Model Catalog: NL-400E (Lot serial: Before MX151001); Model Catalog: NL-300E (Lot serial: Before MX151001); Model Catalog: NL-250E (Lot serial: Before MX151001); Model Catalog: NL-200EL (Lot serial: Before MX151001); Model Catalog: B-709000514 (Lot serial: N/A); Model Catalog: B-705000508 (Lot serial: N/A); Model Catalog: B-701000507 (Lot serial: N/A); Model Catalog: B-107600020 (Lot serial: N/A); Model Catalog: B-107500020 (Lot serial: N/A); Model Catalog: B-709000502 (Lot serial: N/a); Model Catalog: B-709000500 (Lot serial: N/a)
  • Product Description
    knee undersleeve;necloc;unloader lite;unloader xt extreme;papoose infant immobilizer;knee shield (patella cup);rebound diabetic walker;suspenders;rebound cartilage;form fit OA wraparound;miami j;rebound air walker;unloader custom
  • Manufacturer
    OSSUR HF

Manufacturer

OSSUR HF
  • Manufacturer Address
    REYKJAVIK
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    HC