Zimmer, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2213-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."

Product Classification:

Class II

Date Initiated: July 18, 2012

Date Posted: August 22, 2012

Recall Number: Z-2213-2012

Event ID: 62540

Reason for Recall:

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

Status: Terminated

Product Quantity: 252 (210 in USA)

Code Information:

Part 00-4309-028-01: Lot 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60842967, 60739623, 60896979, 60936815, 61019785, 61051017

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated