The Recall Desk

FDA (Devices) recall action 81766

Smith & Nephew, Inc. recalled 4 products on 2019-04-03

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-04-03
Critical
0
Units
241

Why these products were recalled

Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Distribution
    2 states