Z-2199-2013Class II

AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis...

Name: Z-2199-2013 AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis...
Creator: Tornier, Inc
Published: 2013-08-13
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2013-08-13 / Terminated / root cause: design

FDA source

Tornier, Inc began a recall of AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the... on 2013-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2199-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-13
Posted: 2013-09-13
Terminated: 2015-03-03
Recalling firm: TORNIER Inc.
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.
Product code: HTZ Instrument, Cutting, Orthopedic
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
Root cause tag: design
FDA root cause: Device Design
Action: Tornier sent an "Urgent Medical Device Recall" letter dated August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were advised to cease further use and distribution of the product and to contact all end users. Also requested the completion and return of the attached questionnaire via fax to 952-236-4007, e-mail to [email protected] or using the envelope provided. We apologize for the incovenience and thank you in advance for your cooperation in this matter. If you have any questions please contact our Customer Service Department at 1-888 494-7950.
Quantity in commerce: 2,298 (1045 US, 1253 OUS)
Distribution: .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2199-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2199-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13

Product code HTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)