FDA Device recall Z-2199-2013
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor by Tornier, citing following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2199-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-13 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tornier |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MD, MI, MN, NC, NE, NJ, OH, OR, PA, PR, TX |
Product
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.
Reason
Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2013%22
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