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 ceme
Check against the official notice below — it lists the full affected range.
Arthrex, Inc. is recalling 2,378 units of Arthrex IBalance TKA Tibial Tray devices in sizes 2 through 6 that were distributed nationwide. The devices have a smooth texture on the outer metal surface, which differs from the intended textured outer surface design.
The recall affects specific batch numbers for each device size, with detailed lot and code information provided for identification. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 2,378 units. Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.