device · product 1 of 1
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).
- Recall number
- Z-1195-2016
- Initiated
- December 17, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Arthrex, Inc.
- Quantity
- 2,378 units.
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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.
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.
Distribution pattern
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.