Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, ...
FDA Device Recall #Z-1195-2016 — Class II — December 17, 2015
Recall Summary
| Recall Number | Z-1195-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arthrex, Inc. |
| Location | Naples, FL |
| Product Type | Devices |
| Quantity | 2,378 units. |
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.
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.
Lot / 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.
Other Recalls from Arthrex, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0465-2023 | Class II | Small Joint OATS Set, REF AR-8981-06S, 6mm; and... | Nov 2, 2022 |
| Z-1035-2022 | Class II | K-Wire, 1.35 mm x 170 mm | Mar 25, 2022 |
| Z-2107-2021 | Class II | Suture Anchor, BioComposite SwiveLock C, 5.5 mm... | Jun 14, 2021 |
| Z-1380-2021 | Class II | Tibial Opening Wedge Osteotomy Plate, Titanium,... | Mar 11, 2021 |
| Z-1310-2021 | Class II | Drill Bit, Cannulated, 5.0 mm - Product Usage: ... | Feb 24, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.