AEQUALIS Reversed II or AEQUALIS Reversed Fracture recall
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray…
Why was AEQUALIS Reversed II or AEQUALIS Reversed Fracture recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all lots
- Product
- AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray…
- Recalling firm
- Tornier, Inc
- Quantity
- 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
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)