The Recall Desk

FDA (Devices) recall action 68440

DePuy Orthopaedics, Inc. recalled 3 products on 2014-07-30

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-07-30
Critical
0
Units
14,904

Why these products were recalled

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

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

1–3 of 3

  • ModerateFDA (Devices)··2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.

    Product
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2014-07-30

    DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments

    DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Distribution
    49 states