The Recall Desk

FDA (Devices) recall action 66968

Zimmer, Inc. recalled 3 products on 2014-01-08

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
2014-01-08
Critical
0
Units
64

Why these products were recalled

Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

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)··2014-01-08

    Zimmer Recalls CPT Hip System Components Due to Incorrect Packaging

    Zimmer is recalling specific CPT Hip System parts because they were packaged in the wrong outer cartons, though the product labels are correct.

    Product
    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis…
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2014-01-08

    Zimmer Recalls Reverse Glenosphere and Other Devices Due to Packaging Error

    Zimmer is recalling specific lots of medical devices because they were packaged in incorrect outer cartons, though the product labels are correct.

    Product
    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral…
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2014-01-08

    Zimmer Recalls Hip and Shoulder Devices Packaged in Incorrect Cartons

    Zimmer is recalling specific lots of hip and shoulder devices due to incorrect outer packaging. Product labels are correct, but the outer cartons were wrong.

    Product
    Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal…
    Category
    Distribution
    19 states