Ossur North America Inc

Serial numbers: 6918 ¿ 7569

Physical Medicine Devices

1

No

Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.

Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.

Serial numbers: 38198 ¿ 40858 including the following repaired units outside the stated range. 18989,19232, 27029, 27804, 28629, 28923, 30538, 31033, 31104, 31108, 31110, 31111, 31113, 32040, 32229, 32293, 32352, 32528, 32556, 32704, 32712, 32849, 33016, 33035, 33038, 33435, 33626, 33644, 33770, 33963, 34025, 34032, 34131, 34205, 34257, 34331, 34362, 34448, 34544, 34562, 34578, 34631, 34753, 34756, 34783, 34870, 34926, 34994, 35125, 35257, 35328, 35412, 35755, 35810, 35819, 35845, 35969, 35981, 36157, 36209, 36391, 36636, 36665, 36733, 36871, 36902, 36955, 36960, 37098, 37114, 37128, 37147, 37172, 37243, 37255, 37291, 37310, 37554, 37625, 37717, 37788, 37910, 37987, 38047, 38197.

Physical Medicine Devices

1

No

Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.

Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.

Serial numbers: 14466 ¿ 16053 including the following repaired units outside the stated range. 12588, 13131, 13216, 13236, 13265, 13363, 13487, 13573, 13598, 13799, 13967, 14028, 14032, 14127, 14143, 14158, 14159, 14370.

Physical Medicine Devices

1

No

Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.

Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.

Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.

Physical Medicine Devices

1

No

Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.

Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.

RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.

Physical Medicine Devices

1

No

Nationwide.

VSP Shock Module (as part of a prosthetic foot).