Howmedica Osteonics Corp.

Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Orthopedic Devices

2

Yes

Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.

Knee Prosthesis, Sterile, Single-Use devices || Product Usage: || The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A

Orthopedic Devices

2

Yes

USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 || The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.

Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304

Orthopedic Devices

2

Yes

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535

Lot: 56211103, 56211401, 56211704, 57284004

Orthopedic Devices

2

Yes

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737