Zimmer Surgical Inc: Medical Device Recall in 2015 - (Recall #: Z-2349-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

Product Classification:

Class II

Date Initiated: June 24, 2015

Date Posted: August 12, 2015

Recall Number: Z-2349-2015

Event ID: 71575

Reason for Recall:

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Status: Terminated

Product Quantity: 330 units

Code Information:

Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.

Distribution Pattern:

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.

Voluntary or Mandated:

N/A