AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor — Class II medical device recall Z-2199-2013
Terminated recall by Tornier, Inc, reported 2013-09-25, distributed in AL, AZ, CA, CO, CT, FL, GA, IL…. Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a
| Recall number | Z-2199-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-09-13 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2015-03-03 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MD, MI, MN, NC, NE, NJ, OH, OR, PA, PR, TX |
| Countries outside the US | AR, AU, BE, CA, CH, CO, DE, ES, FI, FR, GB, HK, IL, IT, MX, NL, SI, ZA |
| Reason classes | device malfunction |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2199-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.