Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, ...
FDA Recall #Z-1195-2016 — Class II — December 17, 2015
Product Description
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).
Reason for Recall
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
Recalling Firm
Arthrex, Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,378 units.
Distribution
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.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.