Z-2215-2012 Class II Terminated
FDA device recall Z-2215-2012 was initiated by Zimmer, Inc. on Jul 18, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 17, 2014). Affected quantity: 212 (179 USA).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2012
- Initiation Date
- Jul 18, 2012
- Termination Date
- Apr 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212 (179 USA)
Product Description
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. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
Code Information
Part 00-4309-029-01: Lot 60535162, 60545338, 60576488, 60605855, 60637022, 60689253, 60772974, 60875277, 60918060, 60989817, 61011689, 61024161, and 61051024.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2215-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026