Arthrex IBalance TKA Tibial Tray Size 2 — Class II medical device recall Z-1195-2016
Terminated recall by Arthrex, Inc., reported 2016-03-30, distributed nationwide. Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous th
| Recall number | Z-1195-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2015-12-17 |
| Classified | 2016-03-18 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,378 units |
| UPC / GTIN / UDI-DI | 00888867106703, 00888867106710, 00888867106727, 00888867106734, 00888867106741, 00888867106758, 00888867106765 |
| Lot numbers | 1191337, 1191338, 1191339, 1191341, 1191342, 1206164, 1206165, 1206166, 1206167, 1206168, 1206169, 1206170, 1206172, 1206173, 1206176, 1206177, 1206178, 1206179, 1206180, 1206181, 120800, 1224471, 1227387, 1227388, 1228632, 1233620, 1233621, 1251021, 1251022, 1257195, 1272728, 1272729, 1272730, 1281699, 1289648, 1289653, 1289654, 1289736, 1292154, 1292161 and 140 more |
| Model numbers | AR-503-TTTC, AR-503-TTTD, AR-503-TTTE, AR-503-TTTF, AR-503-TTTG, AR-503-TTTH, AR-503-TTTJ |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1195-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.