Z-2199-2013 Class II Terminated
FDA device recall Z-2199-2013 was initiated by Tornier, Inc on Aug 13, 2013 and is designated Class II. 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… The recall status is terminated (terminated Mar 3, 2015). Affected quantity: 2,298 (1045 US, 1253 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 25, 2013
- Initiation Date
- Aug 13, 2013
- Termination Date
- Mar 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,298 (1045 US, 1253 OUS)
Product Description
Reason for Recall
Distribution Pattern
.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
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2199-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026