Arthrex, Inc.

Size 2 Unique Device Identifier: 00888867106703 Batch #'s: 927692, 915207, 982771, 979834, 982774, 1206164, 1206165, 1206167, 1206166, 1227388, 1227387, 1257195, 1233620, 1289648, 1233621, 1289653, 1289736, 1289654, 1336430, 1336431, 1305721, 1306332, 1352062, 1336433, 1336436, 1352058, 1352063, 1376104, 1376106, and 1376107.  Size 3 Unique Device Identifier: 00888867106710 Batch #'s: 780838, 952789, 1206169, 1206170, 1206168, 1191337, 1191337, 1272728, 1297048, 1297044, 1297049, 1272730, 1272729, 1307262, 1297060, 1297057, 1297365, 1307263, 1336445, 1307267, 1336451, 1336448, 1336451, 1307265, 1336453, 1346958, 1346962, 1346982, 1346994, 1346965, 1336452, 1379085, 1379104, 1379110, 1379113, 1379114, 1346999, and 1379084.  Size 4 Unique Device Identifier: 00888867106727 Batch #'s: 894339, 913623, 874733, 876482, 876478, 1191338, 1206172, 1206173, 1297075, 1297084, 1315459, 1297086, 1297366, 13115453, 1315454, 1315459, 1315462, 1315464, 1336466, 1336465, 1336467, 1336455, 1336468, 13336469, 1356527, 1356530, 1356531, 1356529, 1356574, 1379205, 1379203, 1379204, 1379206, 1379200, 1356576, 1379196, and 1379201. Size 5 Unique Device Identifier: 00888867106734 Batch #'s:780840, 971202, 1206176, 1206177, 1356586, 1322523, 1380216, 1380223, 1380224, 1356588, 1380221, 1380226, 1555653, and 1555654. Size 6 Unique Device Identifier: 00888867106741 Batch #'s:780841, 970368, 1206178, 1206179, 1322459, 1322460, 1322524, 1357785, 1380243, 1380244, 1380245, 1380246, 1357786, and 1380242. Size 7 Unique Device Identifier: 00888867106758 Batch #'s: 780842, 982767, 984546, 1206180, 1337230, 1206181, 1337234, 1337237, 1337240, 1337241, 1337256, 1358297, 1358299, 1358298, 1358300, 1358302, 1380708, 1380709, and 1380710. Size 8 Unique Device Identifier: 00888867106765 Batch #'s: 913624, 970865, 957056, 1191342, 1224471, 120800, 1191341, 1191339, 876484, 876485, 1228632, 1251021, 1292154, 1251022, 1281699, 1292161, 1293756, 1293758, 1307294, 1307295, 1308538, 1337262, 1337300, 1337303, 1347012, 1347013, 1337325, 1347014, 1380743, 1347025, 1380747, 1380748, and 1380742.

Orthopedic Devices

2

Yes

Nationwide Distribution -- AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI and District of Columbia.

Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. || Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.

Orthopedic Devices

2

Yes

Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.

Arthrex Deltoid Ligament Reconstruction Implant System. || Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018

Orthopedic Devices

2

Yes

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)

Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021

Orthopedic Devices

2

Yes

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)

Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018

Orthopedic Devices

2

Yes

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)

Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching