The Recall Desk

FDA (Devices) recall action 62540

Zimmer, Inc. recalled 4 products on 2012-08-22

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
2012-08-22
Critical
0
Units
—

Why these products were recalled

Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainle

Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain

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

1–4 of 4

  • HighFDA (Devices)··2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.

    Product
    00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, pl
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-22

    Zimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.

    Product
    00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.

    Product
    00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Th
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units made of 455 stainless steel.

    Product
    Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, plac
    Category
    Distribution
    0 states