Recall Z-1195-2016— Arthrex, Inc.
Class II · Terminated
Class II FDA medical device recall by Arthrex, Inc., initiated 2015-12-17, terminated 2016-12-14. It names one FDA 510(k) clearance: K081127. 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: 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.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-17
- Terminated
- 2016-12-14
- Firm location
- Naples, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.